Percutaneous endoscopic gastrostomy versus nasogastric tube feeding for adults with swallowing disturbances

  • Review
  • Intervention

Authors


Abstract

Background

A number of conditions compromise the passage of food along the digestive tract. Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to complications such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia. Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period. There is a high demand for PEG in patients with swallowing disorders, although there is no consistent evidence about its effectiveness and safety as compared to NGT.

Objectives

To evaluate the effectiveness and safety of PEG compared with NGT for adults with swallowing disturbances.

Search methods

We searched The Cochrane Library, MEDLINE, EMBASE, and LILACS from inception to January 2014, and contacted the main authors in the subject area. There was no language restriction in the search.

Selection criteria

We planned to include randomised controlled trials comparing PEG versus NGT for adults with swallowing disturbances or dysphagia and indications for nutritional support, with any underlying diseases. The primary outcome was intervention failure (e.g. feeding interruption, blocking or leakage of the tube, no adherence to treatment).

Data collection and analysis

We used standard methodological procedures expected by The Cochrane Collaboration. For dichotomous and continuous variables, we used risk ratio (RR) and mean difference (MD), respectively with the random-effects statistical model and 95% confidence interval (CI). We assumed statistical heterogeneity when I² > 50%.

Main results

We included 11 randomised controlled studies with 735 participants which produced 16 meta-analyses of outcome data. Meta-analysis indicated that the primary outcome of intervention failure, occurred in lower proportion of participants with PEG compared to NGT (RR 0.18, 95% CI 0.05 to 0.59, eight studies, 408 participants, low quality evidence) and this difference was statistically significant. For this outcome, we also subgrouped the studies by endoscopic gastrostomy technique into pull, and push and not reported. We observed a significant difference favouring PEG in the pull subgroup (RR 0.07, 95% CI 0.01 to 0.35, three studies, 90 participants). Thepush subgroup contained only one clinical trial and the result favoured PEG (RR 0.05, 95% CI 0.00 to 0.74, one study, 33 participants) techniques. We found no statistically significant difference in cases where the technique was not reported (RR 0.43, 95% CI 0.13 to 1.44, four studies, 285 participants).

There was no statistically significant difference between the groups for meta-analyses of the secondary outcomes of mortality (RR 0.86, 95% CI 0.58 to 1.28, 644 participants, nine studies, very low quality evidence), overall reports of any adverse event at any follow-up time point (ITT analysis, RR 0.83, 95% CI 0.51 to 1.34), 597 participants, 6 studies, moderate quality evidence), specific adverse events including pneumonia (aspiration) (RR 0.70, 95% CI 0.46 to 1.06, 645 participants, seven studies, low quality evidence), or for the meta- analyses of the secondary outcome of nutritional status including weight change from baseline, and mid-arm circumference at endpoint, although there was evidence in favour of PEG for meta-analyses of mid-arm circumference change from baseline (MD 1.16, 95% CI 1.01 to 1.31, 115 participants, two studies), and levels of serum albumin were higher in the PEG group (MD 6.03, 95% CI 2.31 to 9.74, 107 participants).

For meta-analyses of the secondary outcomes of time on enteral nutrition, there was no statistically significant difference (MD 14.48, 95% CI -2.74 to 31.71; 119 participants, two studies). For meta-analyses of quality of life measures (EuroQol) outcomes in two studies with 133 participants, for inconvenience (RR 0.03, 95% CI 0.00 to 0.29), discomfort (RR 0.03, 95% CI 0.00 to 0.29), altered body image (RR 0.01, 95% CI 0.00 to 0.18; P = 0.001) and social activities (RR 0.01, 95% CI 0.00 to 0.18) the intervention favoured PEG, that is, fewer participants found the intervention of PEG to be inconvenient, uncomfortable or interfered with social activities. However, there were no significant differences between the groups for pain, ease of learning to use, or the secondary outcome of length of hospital stay (two studies, 381 participants).

Authors' conclusions

PEG was associated with a lower probability of intervention failure, suggesting the endoscopic procedure may be more effective and safe compared with NGT. There is no significant difference in mortality rates between comparison groups, or in adverse events, including pneumonia related to aspiration. Future studies should include details of participant demographics including underlying disease, age and gender, and the gastrostomy technique.

摘要

對於吞嚥困難成人之經皮內視鏡胃造口術與鼻胃管餵食之比較

背景

許多狀況會阻礙了食物沿著消化道的運送。鼻胃管(NGT)餵食是典型且經時間證明的技術,但長期使用會造成鼻翼的病變、慢性鼻竇炎、胃食道逆流及吸入性肺炎等併發症。另一個灌注方法,經皮內視鏡胃造口術(PEG),通常用於需要較長時間的腸內營養。有吞嚥困難的病患身上亦對PEG有高度需求,然而目前沒有和NGT比較其效用及安全性的一致性的證據。

目的

評估在吞嚥困難成人身上PEG對比於NGT之效果與安全性。

搜尋策略

我們搜尋了The Cochrane Library、MEDLINE、EMBASE、與LILACS係至2014年1月的資料,並聯絡主題範圍的主要作者。搜尋中無文獻語言的限制。

選擇標準

我們計畫納入在吞嚥障礙或吞嚥困難、有營養支持跡象、伴有任何潛在疾病之成人,比較PEG及NGT的隨機對照試驗。主要結果為介入治療失敗(例如:餵食被中斷、導管堵塞或洩露、無法遵行治療)。

資料收集與分析

我們使用被Cochrane Collaboration採納的標準統計學方法。就類別與連續性變項而言,我們採用風險比(RR)與平均差(MD),分別使用隨機效應統計模式與95%信賴區間(CI)。當I² > 50%時,我們假設統計為異質性。

主要結果

我們納入11個隨機對照試驗,共包含 735名參與者,16筆統合分析結果資料。統合分析指出介入治療失敗在PEG組的比例較NGT組少(RR 0.18, 95%CI 0.05 至 0.59, 8個試驗,408位參與者,證據品質低),且具有統計意義。對於此結果,我們亦將內視鏡胃造口技術做牽引法(pull)推進法(push)未記載的研究進行子群分析。我們觀察到牽引組中傾向PEG的顯著差異(RR 0.07, 95%CI 0.01 至 0.35, 3個試驗, 90位參與者)。而推進組僅含一個臨床試驗,結果傾向PEG(RR 0.05, 95%CI 0.00 至 0.74, 1個試驗, 33位參與者)。在未報告技術的子群中則沒有統計上的顯著差異(RR 0.43, 95%CI 0.13 至 1.44, 4個試驗, 285位參與者)。

以下次級結果在統合分析群組間並沒有顯著地統計差異,包含死亡率(RR 0.86, 95%CI 0.58 至 1.28, 644位參與者, 9 個試驗, 證據品質非常低),任何追蹤時間點的任何不良事件整體報告(治療意向分析法(ITT), RR 0.83, 95%CI 0.51 至 1.34, 597位參與者, 6個試驗, 證據品質中等),特定不良事件包含肺炎(吸入性) (RR 0.70, 95%CI 0.46 至 1.06, 645位參與者, 7個試驗, 證據品質低),或統合分析營養狀況包含相對於基準值的體重變化、中臂肌肉環圍,儘管有證據傾向支持PEG組在相對於基準值改變中臂肌肉環圍變化量(MD 1.16, 95% CI 1.01 至 1.31,115位參與者, 2個試驗)和血中白蛋白濃度較高(MD 6.03, 95% CI 2.31 至 9.74, 107位參與者)。

統合分析的群組間在次級結果腸道營養需時上沒有統計顯著差異(MD 14.48, 95% CI -2.74 至 31.71; 119位參與者, 2個試驗)。於生活品質測量(EuroQol)結果,在2個試驗共133位參予者進行統合分析,不便性(RR 0.03, 95% CI 0.00 至 0.29)、不舒服(RR 0.03, 95% CI 0.00 至 0.29)、身體意象改變(RR 0.01, 95% CI 0.00 至 0.18; P = 0.001)和社交活動(RR 0.01, 95% CI 0.00 to 0.18),介入結果傾向支持PEG,換言之,較少參與者認為PEG帶來不便、不舒服、或影響參與社交活動。然而,群組間在疼痛、容易學習上手或次級結果住院時間上並沒有統計上顯著差異(2個試驗, 381位參與者)。

作者結論

PEG與較低的介入治療失敗機率有關,顯示內視鏡程序與NGT相比可能更為有效且安全。在死亡率、或包含呼吸相關肺炎的不良事件,兩組間並沒有顯著性地差異。未來的研究應包含包括參與者人口統計學細項,包括潛在疾病、年齡和性別以及胃造口術技術。

Plain language summary

Nutritional support for adults with swallowing difficulties

Background

A number of conditions compromise the transport of food along the digestive tract. Patients with swallowing disturbances can develop low nutritional status, which affects their recovery from illness, surgery, and injury. Conditions associated with swallowing disorders include stroke, neurological diseases, dementia, cancers of the head and neck, amyotrophic lateral sclerosis, physical obstruction, and dysphagia from stroke. Nasogastric tube feeding is a time proven technique to provide nutritional support; the tube can be inserted by a nurse. Percutaneous endoscopy gastrostomy (PEG) involves a feeding tube inserted directly into the stomach through the abdomen and is particularly useful when enteral nutrition is needed for a length of time.

Review question

Prolonged use of a nasal tube can lead to adverse events such as damage to the nose and larynx, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia (which can result from inhalation of stomach contents leading to lower respiratory tract infection and pneumonia).

Study characteristics

We obtained updated evidence for this review from 11 randomised controlled studies comparing a nasogastric tube with PEG in a total of 735 patients. Seven studies measured treatment failure i.e. feeding interruption, blocking or leakage of the feeding tube in 408 patients randomised to either a nasal gastric tube or PEG.

Key results

The studies showed a higher probability of treatment failure with a nasal gastric tube. The number of deaths was no different with the two methods; nor was the overall occurrence of adverse events. Participants with PEGs may have a better quality of life.

Quality of the evidence

Possible limitations of this review include the small number of participants in the majority of studies, explained by the high cost of PEG and requirements for endoscopy in its use, the operational challenges to accomplish a clinical trial in this area and the different length of follow-up of the patients in the studies (from less than four weeks to six months). There were clinical differences between the trials, with the participants having different baseline diseases and different techniques used to insert the PEG. The findings of the present review of the literature should be interpreted with caution, given that there were methodological issues with most of the included studies which increase the risk of bias in the trial. This systematic review of the literature is valuable in analysing 11 studies, with a sample size of 735 patients. Nevertheless, further randomised clinical trials that adopt a rigorous method are warranted.

淺顯易懂的口語結論

吞嚥困難成人的營養支持

研究背景

許多狀況會阻礙食物沿著消化道的運送。有吞嚥困難的成人可能會產生營養條件較低的情形,影響他們從疾病中、手術及受傷中復原。與吞嚥困難有關的狀況包含中風、神經系統疾病、癡呆、頭頸癌症、肌肉萎縮性脊髓側索硬化症、身體物理性阻塞和中風造成的吞嚥困難。鼻胃管餵食是經時間證實認可的技術,可提供營養支持,導管可由護理師插入。經皮內視鏡胃造口術(PEG)涉及直接通過腹部到達胃部的胃食管插入,在需要長時間的腸內營養時特別有用。

文獻回顧問題

鼻管的長期使用會導致鼻子與喉部損害、慢性鼻竇炎、胃食道逆流與吸入性肺炎(吸入胃中內容物導致下物吸道感染和肺炎)等併發症。

研究特徵

我們納入11個隨機對照試驗中取得更新的證據,在總計735名病人中比較鼻胃管與PEG。7個研究測量了餵食中斷、餵食管堵塞或洩露、或是不遵守治療等情況,408名病人隨機分配至鼻胃管或PEG組。

主要结果

研究顯示在鼻胃管組中有較高的治療失敗機率。在兩個方法中的死亡數沒有差異;整體的併發症發生情形也沒有差異。PEG組的病人有較佳的生活品質。

證據品質

此文獻回顧的可能限制包含大多研究中參與人數少,可由PEG需較高成本以及其使用中需要內視鏡來解釋,為執行此領域的臨床試驗的挑戰,及研究中病人後續追蹤的時間長短不等(由不超過4週到6個月)。各研究間存在臨床差異,包含病患的不同原發疾病,放置PEG的技術不同。目前文獻回顧的結果應被小心地解讀,因為大多納入研究的統計方法可能增加偏差風險。此系統性文獻回顧分析11個研究,包含樣本數735名病人。然而,進一步採用嚴格方法的隨機臨床試驗仍是必要的。

譯註

翻譯者:周孜容
服務單位:臺大醫院實習醫師
職稱:臺北醫學大學醫學系七年級

審稿者:林彥仲
服務單位:台北醫學大學附設醫院腎臟科
職稱:主治醫師

本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行
聯絡E-mail:cochranetaiwan@tmu.edu.tw

Laički sažetak

Potpomognuta prehrana u odraslih koji imaju poteškoće s gutanjem

Dosadašnje spoznaje

Velik broj bolesti remeti prolazak hrane kroz probavni trakt. Pacijenti s poteškoćama u gutanju mogu razviti nizak prehrambeni status koji utječe na njihov oporavak od bolesti, operacije i ozlijede. Stanja povezana s poremećajima gutanja uključuju moždani udar, neurološke bolesti, demenciju, rakove glave i vrata, amiotrofičnu lateralnu sklerozu, fizičke prepreke i disfagiju uslijed moždanog udara. Hranjenje kroz nazogastričnu sondu je tehnika koja dokazano pruža prehrambenu podršku. Sondu može umetnuti medicinska sestra. Perkutana endoskopska gastrostoma (PEG) uključuje direktno umetanje sonde za hranjenje u trbuh kroz abdomen, te je osobito korisna kada je enteralna prehrana (koja zaobilazi usta) potrebna duže vrijeme.

Istraživačko pitanje

Produženo korištenje nosne sonde može dovesti do štetnih događaja kao što su oštećenje nosa i grkljana, kronične upale sinusa, gastroezofagealne refluksne bolesti, apiracijske upale pluća (što može nastati udisanjem sadržaja trbuha što vodi do infekcija nižeg dijela dišnog trakta i upale pluća).

Obilježja istraživanja

Najnovije informacije za ovaj Cochrane sustavni pregled dobivene su iz 11 randomiziranih kontroliranih istraživanja koja uspoređuju nazogastričnu sondu s PEG-om kod ukupno 735 pacijenata. Sedam je istraživanja mjerilo neuspjehe npr. prekid hranjenja, blokiranje ili curenje sonde za hranjenje kod 408 pacijenata gdje su nasumično ispitane želučane sonde ili PEG.

Ključni rezultati

Istraživanja su pokazala veću vjerojatnost neuspješnog liječenja s nosno-želučanom (nazogastričnom) sondom. Broj smrti nije se razlikovao kod te dvije metode; niti cjelokupna pojava štetnih događaja. Sudionici s PEG-om možda imaju veću kvalitetu života.

Kvaliteta dokaza

Moguća ograničenja ovog pregleda uključuju mali broj sudionika u većini istraživanja, što se može objasniti velikom cijenom PEG-a i zahtjevom za endoskopijom, operativnim izazovima u postizanju kliničkog ispitivanja u ovom području, te različitom dužinom kontrola pacijenata u istraživanju (od manje od četiri tjedna do šest mjeseci). Postoje kliničke razlike u ispitivanjima, s pacijentima koji imaju različite osnovne bolesti i različite tehnike koje su se koristile pri umetanju PEG-a. Zaključci ovog pregleda literature bi se trebali tumačiti s oprezom jer su u većini uključenih studija utvrđeni metodološki problemi, zbog čega je povećan rizik od pristranosti u istraživanju. Sustavni pregled literature je vrijedan jer analizira 11 istraživanja, s uzorkom od 735 pacijenata. Usprkos tome, potrebna su daljnja randomizirana klinička istraživanja koja će biti metodološki kvalitetno provedena.

Bilješke prijevoda

Hrvatski Cochrane
Prevela: Maja Vuleta
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Резюме на простом языке

Нутритивная поддержка взрослых с нарушениями глотания

Актуальность

Существует ряд состояний, при которых нарушается транспорт пищи по желудочно-кишечному тракту. Нарушения глотания могут привести к низкому нутритивному статусу (состоянию питания) пациентов, что может повлиять на восстановление после болезни, операции или травмы. Нарушения глотания могут возникнуть при таких состояниях, как инсульт, неврологические заболевания, деменция, опухоли головы и шеи, боковой амиотрофический склероз, а также вследствие механической обструкции. Кормление через назогастральный зонд – это проверенная временем техника для обеспечения нутритивной поддержки; трубку может вводить медсестра. Чрескожная эндоскопическая гастростомия (ЧЭГ) представляет собой процедуру введения зонда для питания через брюшную стенку непосредственно в желудок, что особенно удобно для пациентов, нуждающихся в энтеральном питании на протяжении длительного времени.

Вопрос обзора

Длительное использование назального зонда может привести к таким неблагоприятным событиям, как повреждение носа и гортани, хронический синусит, гастроэзофагеальный рефлюкс и аспирационная пневмония (возникающая в результате попадания содержимого желудка в дыхательные пути, что приводит к инфекции нижних дыхательных путей и пневмонии).

Характеристика исследований

Мы получили обновленные доказательства для этого обзора из 11 рандомизированных контролируемых исследований, в которых сравнивали применение назогастрального зонда с ЧЭГ у 735 пациентов. В 7 исследованиях оценивали неэффективность лечения, т.е. прерывание кормления, блокирование или нарушение герметичности трубки у 408 пациентов, которые в случайном порядке (рандомизированно) были распределены в группы для получения питания либо через назогастральный зонд, либо путем ЧЭГ.

Основные результаты

Исследования показали, что применение назогастрального зонда, вероятно, менее эффективно. Число смертей и частота возникновения неблагоприятных событий не различались при применении этих двух методов. Качество жизни участников, получавщих питание путем ЧЭГ, возможно, было более высоким.

Качество доказательств

Возможные ограничения в этом обзоре могут быть связаны с небольшим числом участников в большинстве исследований, что можно объяснить высокой стоимостью ЧЭГ и необходимостью в эндоскопии при ее применении; операционными проблемами, связанными с осуществлением клинического исследования в этой области и различной продолжительностью наблюдения за пациентами в исследованиях (от менее, чем 4 недель, до 6 месяцев). Были клинические различия между исследованиями – у участников были различные заболевания и у них применяли различные техники ЧЭГ. Результаты этого обзора литературы следует интерпретировать с осторожностью, учитывая наличие методологических проблем у большинства включенных исследований, что повысило риск смещения. Этот систематический обзор литературы представляет ценность в анализе 11 исследований с размером выборки в 735 пациентов. Тем не менее, желательно проведение дальнейших рандомизированных клинических испытаний, придерживающихся строгой методологии.

Заметки по переводу

Перевод: Алексеева Анастасия Андреевна. Редактирование: Кукушкин Михаил Евгеньевич, Юдина Екатерина Викторовна. Координация проекта по переводу на русский язык: Cochrane Russia - Кокрейн Россия (филиал Северного Кокрейновского Центра на базе Казанского федерального университета). По вопросам, связанным с этим переводом, пожалуйста, обращайтесь к нам по адресу: cochrane.russia.kpfu@gmail.com; cochranerussia@kpfu.ru

Summary of findings(Explanation)

Summary of findings for the main comparison. Percutaneous endoscopic gastrostomy compared with nasogastric tube feeding for adults with swallowing disturbances
  1. 1 Design limitation (risk of bias), unclear sequence generation, allocation concealment and loss to follow-up.
    2 Relatively few participants and few events and/or wide confidence intervals
    3 Widely differing estimates of the treatment effect (i.e. heterogeneity or variability in results) across studies

Percutaneous endoscopic gastrostomy compared with nasogastric tube feeding for adults with swallowing disturbances
Patient or population: adult patients with swallowing disturbances
Settings: in-patient
Intervention: percutaneous endoscopic gastrostomy
Comparison: nasogastric tube feeding
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Nasogastric tube feeding Percutaneous endoscopic gastrostomy
Treatment failure
Feeding interruption, blocking or leakage of the tube, non-adherence
Follow-up: 0 to 6 months
Study population RR 0.18
(0.05 to 0.59)
408
(8 studies)
⊕⊕⊝⊝
low 1,3

The subgroup of stroke/neurological diseases was associated with a lower risk of intervention failure compared with the subgroup composed of mixed diseases.

Favours PEG

391 per 1000 70 per 1000
(20 to 231)
Low
375 per 1000 30 per 1000
(7 to 124)
High
319 per 1000 102 per 1000
(26 to 421)
Mortality irrespective of follow-up time
Follow-up: 0 to 6 months
366 per 1000 315 per 1000
(212 to 469)
RR 0.86
(0.58 to 1.28)
644
(9 studies)
⊕⊝⊝⊝
very low 1,2,3
Favours neither PEG nor NGT.
Pneumonia irrespective of follow-up time
Follow-up: 0 to 6 months
415 per 1000 291 per 1000
(24 to 45)
RR 0.7
(0.46 to 1.06)
645
(7 studies)
⊕⊕⊝⊝
low 1,3
Favours neither PEG nor NGT.
Adverse events irrespective of follow-up time
Follow-up: 0-17 months
458 per 1000 380 per 1000
(234 to 614)
RR 0.83
(0.51 to 1.34)
597
(6 studies)
⊕⊕⊕⊝
moderate 1,3
Favours neither PEG nor NGT.
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

A number of conditions compromise the passage of food along the digestive tract. Disturbances may be due to blockage, as seen in stenosis and cancer of the stomach or larynx, or due to swallowing difficulties such as in genetic diseases, stroke sequelae, cranial encephalic trauma, brain tumours, and amyotrophic lateral sclerosis (Heemskerk 2014; Löser 2005; Piecuch 2013; Schneider 2014). Several approaches are available to provide nutritional support (Nugent 2013). Nasogastric tube (NGT) feeding is a classic, time-proven technique, although its prolonged use can lead to adverse events such as lesions to the nasal wing, chronic sinusitis, gastro-oesophageal reflux, and aspiration pneumonia (Bastow 1986; Beavan 2010). Two meta-analyses comparing tube placement into the stomach or duodenum revealed no significant difference between the methods in terms of length of hospital stay, mortality, or adverse events (Ho 2006; Marik 2003). In addition to adverse events, the need to change the tube due to blockage inherent to its narrow gauge coupled with its disagreeable appearance in social settings have led to the election of alternative techniques whenever possible (Zaherah 2012).

Gastrostomy has been used to gain access to the stomach for long-term enteral feeding in patients with swallowing limitations who require nutritional support. The main criteria for indicating gastrostomy are (i) a reasonable prospect of patient survival and (ii) normal intestinal function (Friginal-Ruiz 2011). This surgical procedure was first carried out successfully in humans in 1876, by Verneuil in France. Following various modifications, Stamm devised the technique most frequently used to this day (Ljungdahl 2006). In 1980, Gauderer et al described a new technique of feeding tube placement in gastrostomy using endoscopy, called percutaneous endoscopic gastrostomy (PEG). This involves a local anaesthetic and does not require laparotomy (Gauderer 1980). Since the introduction of PEG, a number of studies comparing methods of gastrostomy have been conducted, such as operative, push and pull PEG techniques (Köhler 2014; Stiegmann 1990; Tucker 2003).

Previous systematic reviews and meta-analyses on enteral nutrition approaches have been performed, but not with the broad scope we propose. Langmore 2006 published a meta-analysis that investigated enteral nutrition, specifically in amyotrophic lateral sclerosis, comparing the use of several types of feeding tubes in patients being fed orally. However, they did not find any controlled or randomised studies. Another meta-analysis compared nutrition by endoscopic gastrostomy and NGT including only post-stroke patients (Bath 1999). Thereafter, a number of controlled and randomised studies were published that compared the two methods of nutritional support in stroke patients and those admitted to intensive care units with a range of different pathologies, as well as individuals on mechanical ventilation (Dennis 2005; Douzinas 2006; Hamidon 2006; McClave 2005).

Assessment of these latest studies in patients with a range of pathologies, together with analysis of the optimal moment to commence nutritional support, warrant mapping by means of a systematic review so as to offer the best evidence available on which to base decisions.

Description of the condition

Malnutrition encompasses overnutrition and undernutrition, but undernutrition is a prevalent, and undesired condition affecting up to 40% of hospitalised patients (Barker 2011). This condition has important causal associations with morbidity and mortality, by affecting, for example, length of stay in hospital; recovery from illness, surgery and injury; cardiac function, weak muscles (including respiratory muscles), with consequent higher risk of thromboembolism, chest infection, and pressure sores (Geeganage 2012; Iwamoto 2014; Löser 2010; Pearce 2002; Valente da Silva 2012). Mortality rates tend to be higher in elderly and undernourished patients in comparison to other subgroups of hospitalised patients (Ordoñez 2013; Valente da Silva 2012). In this sense, swallowing disturbances are of special interest, because of its direct relationship with undernutrition (Poisson 2014).

The clinical diagnosis of swallowing disturbances can be given based on clinical signals such as delay in swallowing, pharyngeal sensibility, abnormality or absence of tongue movements; loosening of water from lips, pocketing of food in the cheek, under the tongue or on the hard palate, coughing or choking while eating or signs of penetration or aspiration (Falsetti 2009; Simons 2014). Although not usually used in daily practice, radiological tests like videofluoroscopic modified barium swallow and videofluoroscopic swallowing study can be used for diagnosis of dysphagia (Finestone 2003; Scheeren 2014; Stec 2008).

Patients with indications for enteral nutrition (nutrients intake by means of feeding tubes) include those with conditions associated with swallowing disorders, such as motor neuron disease and multiple sclerosis; physical obstruction to swallowing, such as oesophageal tumours; an inability to ingest food due to head injury or stroke; and those with anorexia due to an underlying disease such as chronic lung disease, irritable bowel disease, or cancer (Botella Romero 2012; de Aguilar-Nascimento 2011; Fini 2014; Kolaček 2013; Manba 2014). Dysphagic patients and those with anorexia, malabsorption, or excessive catabolism also may need long-term enteral feeding (Le 2010; Gentile 2012; Pearce 2002). Aspiration risk often is an indication for nutritional support using tubes (Corry 2008; Metheny 2010). Enteral nutrition can be provided in the form of drink supplements or, if a patient is unable to take adequate nutritional supplements orally, fed via an enteral tube into the stomach or small bowel (Granell Vidal 2014; Löser 2005).

Description of the intervention

In general, tube systems for artificial enteral nutrition can be positioned by nasal insertion, guided percutaneous application, or surgical techniques (Abdel-Lah Mohamed 2006; Blumenstein 2014; Gopalan 2003; Schröder 2004). The superiority of percutaneously placed gastrostomies compared with the former surgical gastrostomy procedures (that is, Witzel, Stamm, Janeway techniques) has been clearly suggested (Löser 2005; Ljungdahl 2006). Lower complication rates, reduced hospital length of stay and costs have been reported (Grant 1988; Ljungdahl 2006). Most patients who require nutritional support need it for around one month or less, with the nasogastric sound probe being the main way of infusion (Blumenstein 2014; Pearce 2002). The probe used is made of thin polyurethane, size 14 with an internal diameter of 3.3 mm, and is inserted by a trained professional in order to prevent adverse events such as perforation and tracheobronchial location (Hamidon 2006; Löser 2005). Another method of infusion, percutaneous endoscopy gastrostomy (PEG), is generally used when there is a need for enteral nutrition for a longer time period (Löser 2005; Pearce 2002). This procedure can be done by either 'pull' or 'push' techniques, the former being simpler and more frequently used. Both techniques use a silicon probe (for example 24 Fr, internal diameter 5.5 mm). The puncture site is marked with gastroscopic monitoring of the anterior gastric wall in the region of the distal corpus, after adequate local anaesthesia and intravenous sedation (Hamidon 2006; Löser 2005). Prospective studies have shown that the early insertion of the probe via PEG improves the patient’s nutritional state (Hamidon 2006; Norton 1996). Patients treated for head and neck carcinoma have considered PEG to be more acceptable than a NGT, even though persistent dysphagia was associated with PEG (Mekhail 2001). A cohort study verified the acceptability of PEG, with significantly higher survival time and lower aspiration rates (Dwolatzky 2001) compared to NGT. On the other hand, a narrative review (Plonk 2005) reported increased risk of death in stroke patients with PEG compared with NGT and concluded that aspiration pneumonia rates were similar. Published guidelines on enteral nutrition recommend the performing of gastrostomy, preferably endoscopically (Löser 2005).

Radiologically placed gastrostomy (RIG) is another method of enteral nutrition, but operationally different from PEG. RIG is not an endoscopic procedure and utilises fluoroscopy, performed in an interventional radiologic suite (Barkmeier 1998; Chiò 2004).

How the intervention might work

The percutaneous gastronomy probe is of a larger calibre compared with an NGT and is placed in the abdomen. This leads to less interruption of nutrition caused by the probe being withdrawn as well as reduced reflux with consequent aspiration, thus being less embarrassing for the patient (Dwolatzky 2001; Pearce 2002). Patients and carers believe that nutrition via PEG helps in feeding and the ability to cope, being more convenient than NGT (Anis 2006). PEG-related morbidity and mortality are 9.4% and 0.53%, respectively (Wollman 1995). There are, however, exclusive adverse events for endoscopy percutaneous gastrostomy, such as peritonitis, buried bumper syndrome, gastrocolocutaneous fistula, and wound infection (Potack 2008). Adverse events associated with NGT due to its nasogastric insertion and positioning are also cited, including sinusitis, laryngeal ulcerations, pneumothorax, and tracheoesophagic fistula; the latter due to incorrect positioning of the tube (Pearce 2002).

Why it is important to do this review

According to Potack 2008, there is a high demand for PEG in patients with swallowing disorders, with 160,000 to 200,000 PEG procedures performed per year in the USA. This makes PEG the procedure of choice for nutritional support in adults. The same author commented that many such procedures are performed, although there is no consistent evidence about what is the more effective and safe method. Because NGT and PEG are the most commonly used methods for feeding access (Pearce 2002), a systematic review is worth performing to resolve such questions.

Objectives

To evaluate the effectiveness and safety of percutaneous endoscopic gastrostomy (PEG) as compared to a nasogastric tube (NGT) for adults with swallowing disturbances, by updating our previous Cochrane review (Other published versions of this review), assessing the included studies with the revised 'Risk of bias' assessments, and to assess the overall level of evidence using the GRADE approach.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials comparing percutaneous endoscopic gastrostomy (PEG) versus nasogastric tube (NGT) for nutrition in adults with swallowing disturbances.

Types of participants

Adult patients presenting with swallowing disturbances or dysphagia and indications for nutritional support, as identified by the authors of primary studies. Patients with any underlying diseases were also acceptable.

Types of interventions

The comparison arms of interest are as follows.

  • Intervention group: PEG performed by any method (e.g., pull and push methods, others).

  • Control group: NGT irrespective of technique (e.g., conventional and looping).

We did not include studies with radiologically inserted gastrostomy (PRG), nasojejunal tubes, and jejunal tube percutaneous endoscopy gastrostomy (JET-PEG) in this review.

Types of outcome measures

Primary outcomes
  • Intervention failures as defined by any event leading to failure to introduce the tube, recurrent displacement and treatment interruption (feeding interruption, blocking or leakage of the tube, no adherence to treatment) (based on Norton 1996).

Secondary outcomes
  • Nutritional status, as measured by any validated instrument (such as upper-arm skin fold thickness, mid-arm circumference, body weight, serum albumin level, haemoglobin (Ramel 2008)).

  • Mortality.

  • Adverse events (e.g., aspiration, haemorrhage, pneumonia, wound infection, sinusitis, fistula).

  • Time on enteral nutrition.

  • Quality of life, as measured by any validated instrument (such as EUROQoL, SF-36 (Dorman 1997)).

  • Length of hospital stay.

  • Costs and economic issues.

Search methods for identification of studies

Electronic searches

We performed a computerised literature search in, re-running searches from the previous search date (August 2009). We carried out updated searches in September 2011 and in January 2014.

  • The Cochrane Central Register of Controlled Trials (CENTRAL, 2013, Issue 12) and other databases in The Cochrane Library (Appendix 1),

  • Ovid MEDLINE(R) Daily Update January 31, 2014, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present Appendix 2.

  • EMBASE via OVID (Embase 1980 to 2014 Week 05) Appendix 3.

  • LILACS via BIREME (from inception to January 2014) Appendix 4.

Search terms and their synonyms for clinical conditions of interest to us (swallowing disturbance or dysphagia) and interventions of interest (percutaneous endoscopic gastrostomy and nasogastric tube feeding) are given in the appendices. They were adapted for each of the databases. There was no language restriction in the search. Search filters to identify randomised controlled trials involving humans were used when appropriate.

Searching other resources

We compiled a reference list of relevant studies (irrespective of study design) to identify trials with the potential for inclusion. We contacted authors via email requesting the data from unpublished trials. We also tried to identify ongoing trials on the Current Controlled Trials Web site (www.currentcontrolledtrials.gov).

Data collection and analysis

Selection of studies

Two review authors (CG, RA) checked the titles and abstracts found by the search strategy and other sources researched. Whenever titles or abstracts seemed relevant to the review, we analysed them by reading the full article. If they were truly randomised controlled trials that met the previously stated criteria, we included them in the review. If there remained any doubt or disagreement, all of the authors assessed the study in question.

Data extraction and management

Two review authors (CG, DRW) extracted data based on CONSORT (Moher 2001). For the update in 2014, CB with CG and DRW extracted data from new included studies. We settled doubts by consensus of the authors.

Assessment of risk of bias in included studies

Two review authors (CG, RBA, with CB) independently assessed the methodological quality of included studies using the following items (Higgins 2011).

  • Random sequence generation (selection bias) . Biased allocation to interventions due to inadequate generation of a randomised sequence.

  • Allocation concealment (selection bias). Biased allocation to interventions due to inadequate concealment of allocations prior to assignment.

  • Blinding (performance bias and detection bias). Performance bias or detection bias due to knowledge of the allocated interventions after assignment.

  • Blinding of participants and personnel (performance bias). Performance bias due to knowledge of the allocated interventions by participants and personnel during the study.

  • Blinding of outcome assessment (detection bias). Detection bias due to knowledge of the allocated interventions by outcome assessors.

  • Incomplete outcome data (attrition bias). Attrition bias due to amount, nature or handling of incomplete outcome data.

  • Selective reporting (reporting bias). Reporting bias due to selective outcome reporting.

  • Other bias that is bias due to problems not covered elsewhere in the table.

For the above biases, we classified studies according to their risk of systematic error.

  • High risk: when the appropriate method to avoid systematic error was not met.

  • Unclear risk: when the appropriate method to avoid systematic error was not described or the information was not acquired by contacting the authors of primary studies.

  • Low risk: when the appropriate method to avoid systematic error was met.

We did not use performance bias as a criterion to analyse the risk of systematic error since this was not compatible with the characteristics of the intervention.

Measures of treatment effect

For dichotomous and continuous variables, we calculated risk ratio (RR), mean difference (MD), and 95% confidence intervals (CIs). When data from primary studies were not parametric (for example, effects were reported as medians, quartiles) or without sufficient statistical information (such as standard deviations, number of patients), we inserted them into Table 1 if authors did not provide the necessary information.

Table 1. Continuous data unsuitable for inclusion in meta-analyses
  1. BSTF: biceps skin fold thickness
    CI: confidence interval
    IQR: interquartile range
    MAC: mid-arm circumference
    R: range
    TSFT: triceps skin fold thickness

OutcomePEGNGTP valueMean difference
(95% CI)
 n n
mean albumin (at 3 months) (Yata 2001 abstract)3.6423.240< 0.01 
mean albumin (at 6 months) (Yata 2001 abstract)3.9423.140< 0.01 
mean haemoglobin (at 3 months) (Yata 2001 abstract)11.94211.740no significant difference 
mean haemoglobin (at 6 months) (Yata 2001 abstract)12.44211.140no significant difference 
median length of stay (days) (Dennis 2005)34.0 (IQR 17 to 66)16237.0 (IQR 17 to 76)159not reported 
utility mean difference between comparison groups (endpoint)
Derived from EuroQol between comparison groups (endpoint) favouring NGT group, no statistically significant difference (Dennis 2005)
    0.120.035
(-0.024 to 0.093)
median patient overall quality of life at first week (endpoint) (Corry 2008)4.0
(R 2.0 to 7.0)
154.0
(R 2.0 to 7.0)
180.89 
anthropometric parameters (endpoint medians) (Hamidon 2006) 8 10  
median TSFT (mm)20.1
(R 9.6 to 34)
 12.7
(R 9.8 to 32)
 0.076 
median BSFT (mm)0.3
(R 4.8 to 13)
 7.4
(R 4.4 to 15)
 0.533 
median MAC (cm)31.4
(R 22 to 36)
 27.8
(R 21 to 37)
 0.182 
median serum albumin (g/L)39.5
(R 36 to 44)
 36.0
(R 31 to 45)
 0.045 
median change in gastro-oesophageal reflux (%, endpoint) on day 7 (Douzinas 2006)2.7
(R 0 to 10.4)
 10.8
(R 6.3 to 36.6)
 < 0.01 
anthropometric parameters (endpoint medians) (6 weeks) Corry 2008      
upper-arm circumference (mm) at endpoint302.5 (R 270 to 370)15300.0 (R 240 to 352)180.69Mean values stated in text (Page 506) to be 295 vs. 283 mm P = 0.25
median TSFT (mm)

13

(R 10 to 20)

15

12

(R 10 to 23)

180.65The NGT patients had significantly
lower triceps skin fold thickness (9.5 vs 13.5 mm; P = 0.03) than the PEG patients at 6 weeks post-treatment.

Unit of analysis issues

The unit of analysis was based on the individual patient (unit to be randomised for interventions to be compared). We planned to analyse events happening to a person more than once (for example pneumonia, bronchoaspiration) by using risk ratio, which compares the rate of events in the two groups (PEG and NGT) by dividing one by the other. We planned to analyse cross-over study designs separately from the parallel-group randomised controlled trials.

Dealing with missing data

For continuous and dichotomous data, we carried out available case analysis. In this update, for mean values of outcome data with missing standard deviations, we calculated this from the difference between means (Cochrane Handbook for Systematic Reviews of Interventions 7.7.3.3. Higgins 2011). We investigated the effects of making these assumptions by performing sensitivity analyses where appropriate.

Assessment of heterogeneity

We assessed statistical heterogeneity using the I² statistic. We assumed a statistically significant heterogeneity between the estimated effects of included studies with an I² > 50%.

Assessment of reporting biases

We had planned to assess publication bias by preparing a funnel plot, and will do so in future versions of this review if a sufficient number of studies is available. However, we are aware that asymmetry in the funnel plot can be associated with reasons other than that of publication bias (for example, by chance, real heterogeneity, or clinical particulars inherent to each one of the included studies such as patients at high risk for the outcome).

Data synthesis

Qualitative information

We synthesised qualitative information relative to methods, risk of bias, description of participants, and outcomes measures in the Characteristics of included studies table.

Quantitative information

For dichotomous variables, we calculated the risk ratio (RR). For continuous variables, we calculated the mean difference (MD) when studies reported their results through the same variables measured with the same instruments (same units of measure). When continuous data were measured with different instruments (different and non-interchangeable units of measure), we planned to pool them using the standardised mean difference (SMD). We used 95% CIs for all statistical methods to pool data.

Irrespective of the nature of the data, we used a random-effects statistical model as we were expecting substantial clinical and methodological heterogeneity, which could generate substantial statistical heterogeneity.

Subgroup analysis and investigation of heterogeneity

We planned to carry out subgroup analyses using different NGT and PEG methods (for example pull, push, nasal loop, conventional). We assumed that heterogeneity between studies in both the direction and magnitude of estimate effect had a suspected causal relationship (the subgroup characteristic and the estimate of effect), and we have considered these in the Discussion section.

Sensitivity analysis

We planned sensitivity analysis to examine the effects of intention-to-treat (ITT) analysis and available data analysis for dichotomous data. We planned to carry out ITT analysis by using imputation based on the analysis of the total number of randomised participants, irrespective of how the original study authors analysed the data. We assumed that all missing participants experienced the event. The other factors were study quality, trials reported only in abstracts, and testing for fixed-effect and random-effects statistical models.

Results

Description of studies

See Characteristics of included studies and Characteristics of excluded studies for more information.

Results of the search

For details of the process of studies selection, see Figure 1.

Figure 1.

Study flow diagram.

The first literature search (August 2009 to September 2011) yielded 474 hits. From this, 18 papers were retrieved for full text review. Three papers were excluded due to inappropriate study design and intervention. In January 2014, an update search yielded 663 additional records and two additional studies were identified for inclusion in the review.

Included studies

The 11 randomised controlled studies selected were published in English. In many cases the data we required were not available in the published report of the study and we obtained further information from the study investigators (e.g. Bath 2009; Corry 2008b), which were used to estimate the effects of the interventions for clinically relevant outcomes (i.e., treatment failure, mortality, pneumonia, adverse events, and length of hospital stay). Yata 2001 was only available in abstract form, which hampered the gleaning of all the relevant data, and the corresponding author could not be contacted. Data from another study (Bath 1997) came from a systematic review by the same author, and doubts were resolved via email with the corresponding author. Elbadawy 2014 was an unpublished study and we obtained further information by correspondence with the study investigator.

Participants and study design

We sought to compare percutaneous endoscopic gastrostomy (PEG) (n = 373 participants) with nasogastric tube (NGT) (n = 362 participants) placement for enteral feeding in adults (n = 735 total randomised participants).

The sample in Baeten 1992 included patients with different diseases, including neoplasia of the ear, nose, and throat and neurologic and post-operative diseases. The mean age of these patients was 72 years (range: 62 to 82 years). Park 1992 included only patients with dysphagia secondary to neurologic diseases in their sample. The mean age of these patients in the NGT group was 65 years, whereas the mean age of those in the PEG group was 56 years. Norton 1996 and Bath 1997 included in their sample patients with dysphagia after acute stroke with a mean age of 77 years. Yata 2001 studied patients with dysphagia in several diseases, such as dementia, Parkinson’s disease, and cerebrovascular disease. These patients had a mean age of 75.1 years (range: 50 to 96 years) in the PEG group and 76.5 years (range: 38 to 93 years) in the NGT group. Dennis 2005 included in their sample patients who presented with dysphagia after acute stroke. Their mean age was 76 years (SD = 10 years). Douzinas 2006 assessed patients with different diseases, some of whom presented with recurrent or persistent ventilator-associated pneumonia. These patients had a median age of 53 years (range: 20 to 82 years) in the PEG group and 58 years (range: 25 to 85 years) in the NGT group. Hamidon 2006 investigated patients with dysphagia after acute stroke with a median age of 65 years (range: 48 to 79 years) in the PEG group and 72 years (range: 54 to 77 years) in the NGT group. Finally, Corry 2008 included in their sample patients with cancer of the head and neck with a median age of 60 years (range: 46 to 80 years). In Sadasivan 2012, participants had advanced stage two or three squamous cell carcinoma of the head and neck and were scheduled either for radical surgery with adjuvant radiotherapy (RT), chemo-RT, or for concurrent chemo and radiation therapy were included in the study. The age of participants in the study was not reported and we were unable to obtain further data. Elbadawy 2014, included participants with close traumatic severe brain injury in a study to determine whether PEG or NGT resulted in lower rates of ventilator-assisted pneumonia. The mean age of participants in the study was not reported and we were unable to obtain further data.

Interventions and comparisons

The interventions were PEG, inserted by any method, versus NGT. Further details can be found in the Characteristics of included studies tables.

In Elbadawy 2014, a three-arm study, NGT plus intubation was compared with PEG plus intubation and PEG plus tracheostomy. For the purposes of this review, we combined the two PEG groups and compared these results with the NGT group.

Outcomes

Follow-up times varied across the 11 studies analysed. Baeten 1992, Douzinas 2006, Park 1992, and Hamidon 2006 studied patients for no more than four weeks. On the contrary, the follow-up times of Bath 1997, Dennis 2005, Norton 1996, Yata 2001, and Corry 2008 ranged from three to six months. Elbadawy 2014 and Sadasivan 2012 followed up participants at one week, six weeks and six months.

The included studies reported our review outcomes as follows:

Our primary outcome, intervention failure, was reported in eight studies (Baeten 1992; Bath 1997; Corry 2008; Hamidon 2006; Norton 1996; Park 1992; Sadasivan 2012; Yata 2001). Elbadawy 2014 reported the number of adverse events in each group; we requested further information, but the study investigators were not able to provide the number of patients with the primary review outcome of intervention failures (e.g., feeding interruption, blocking or leakage of the tube, no adherence to treatment). Participant non-adherence to treatment was reported in Sadasivan 2012,

Mortality was reported in nine studies (Baeten 1992; Bath 1997; Corry 2008; Dennis 2005; Douzinas 2006; Elbadawy 2014; Hamidon 2006; Norton 1996; Park 1992).

Adverse effects were reported in seven studies (Baeten 1992; Corry 2008; Dennis 2005; Douzinas 2006; Elbadawy 2014; Norton 1996; Sadasivan 2012). Pneumonia, the result of aspirating food into the airway, was reported in seven studies (Baeten 1992; Corry 2008; Dennis 2005; Douzinas 2006; Elbadawy 2014; Norton 1996; Yata 2001). Reflux oesophagitis was reported in Yata 2001.

Two studies additionally reported measures related to the nutritional status of the participants: weight gain (Norton 1996; Sadasivan 2012), mid-arm circumference (Norton 1996; Sadasivan 2012), serum albumin levels (Norton 1996), and haemoglobin levels (Sadasivan 2012).

The length of hospital stay was reported in two studies (Dennis 2005; Elbadawy 2014); and the time of entry nutrition in days was reported in Baeten 1992 and Park 1992.

Other outcome measures included quality-of-life measures using the EORTC QLQ-H&N35 scale in Corry 2008 and Sadasivan 2012. Scores of patient satisfaction and inconvenience of maintaining PEG or NGT by nursing staff were reported in Baeten 1992; it is unclear if these were validated scales. Participant functional ability (modified Rankin scale (MRS)), an indicator of quality of life, was reported in Dennis 2005.

The mean survival time in months was reported in Yata 2001.

Excluded studies

The three excluded studies did not meet the aforementioned inclusion criteria. McClave 2005 conducted a randomised controlled trial without interventions of interest for this review; Mekhail 2001 and Schulz 2009 performed retrospective studies. McClave 2008 was excluded following contact with the corresponding author to clarify the randomisation process employed.

Risk of bias in included studies

See Figure 2 and Figure 3.

Figure 2.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Allocation

The methods employed for allocation by Bath 1997; Corry 2008; Dennis 2005; Elbadawy 2014; Hamidon 2006; Park 1992 were suitable for this procedure; therefore, they were deemed low risk for systemic errors of a methodological nature. The remaining studies in this review (i.e., Baeten 1992; Douzinas 2006; Norton 1996; Sadasivan 2012; Yata 2001) were considered to be unclear for risk of bias because the methods used for allocation were not reported.

The methods used for allocation by Dennis 2005; Baeten 1992; Park 1992; and Norton 1996 were sufficiently sound to ensure concealment of the allocation process. Consequently, they were deemed low risk for systematic errors of a methodological nature. On the contrary, the studies by Bath 1997; Corry 2008; Douzinas 2006; Hamidon 2006; Sadasivan 2012; Yata 2001 were considered to be unclear for risk of bias. Although the authors described random allocation, they did not report the methods used for allocation concealment. No attempt was made to conceal allocation in Elbadawy 2014.

Overall, no unusually large differences were noted in the demographic characteristics of patients from each group on study entry, except in Sadasivan 2012, where there were more participants in the PEG group who had radical surgery and adjuvant radio or chemotherapy, and more participants in the NGT group had concurrent chemo or radio therapy. Participants in the NGT group weighed more at the start of the trial.

Blinding

The characteristics of the interventions compared in this systematic review prevented the patients and physicians from being blinded to the interventions. Eight studies made no mention of blinding data assessors (Bath 1997; Douzinas 2006; Elbadawy 2014; Hamidon 2006; Norton 1996; Park 1992; Sadasivan 2012; Yata 2001). Three studies were considered as of high risk of detection bias, because their authors explicitly described either the absence of (Baeten 1992; Corry 2008), or flawed method of blinding data assessors (Dennis 2005).

Incomplete outcome data

Nine studies clearly reported both missing data and the flow of the patients during the study. As a result, they were considered low risk for systematic errors in follow-up losses. However, Yata 2001 and Sadasivan 2012 did not report losses or patient flow in their work; therefore, the study was considered to be unclear for risk of bias for this domain.

In Park 1992, 18 of the 19 patients in the NGT group presented intervention failure. The researchers did not follow these patients for the full 28 days. In contrast, all 19 patients from the PEG group completed the recommended follow-up period. Despite the significant number of failures in the NGT group, this clinical trial was considered low risk for systematic error for dichotomous variables because the authors clearly described the flow of patients from randomisation through to the study endpoint.

Selective reporting

All of the studies were associated with a low risk of bias, given that relevant outcomes were reported in all cases.

Other potential sources of bias

The following studies were rated as having a high risk of bias: Baeten 1992 (follow-up not previously established), Bath 1997 and Yata 2001 (unpublished studies), Park 1992 (dropout rate of 95% (19/20) in the NGT group due to treatment failure and death).

Effects of interventions

See: Summary of findings for the main comparison Percutaneous endoscopic gastrostomy compared with nasogastric tube feeding for adults with swallowing disturbances

Comparison 1: percutaneous endoscopic gastrostomy versus nasogastric tube

Primary outcomes

Intervention failure

The outcome of intervention failure (e.g., feeding interruption, blocking or leakage of the tube, no adherence to treatment) was reported in eight studies comprising 408 participants (Baeten 1992; Bath 1997; Corry 2008; Hamidon 2006; Norton 1996; Park 1992; Sadasivan 2012; Yata 2001). We were unable to obtain data on overall intervention failure rates in each group from Elbadawy 2014.

Failure occurred in 9.22% (19 out of 206 participants) in the PEG group and 39.11% (79 out of 202 participants) in the NGT group. A meta-analysis of these eight studies using the random-effects model favoured the PEG group, that is, fewer participants in the PEG group experienced an intervention failure (risk ratio (RR) 0.18, 95% confidence interval (CI) 0.05 to 0.59, P = 0.005; Analysis 1.1) (Mantel-Haenszel’s statistical method). We found significant statistical heterogeneity in this analysis; I2 = 73%.

Non-adherence to treatment

Non-adherence to treatment at six weeks was reported in only one study, Sadasivan 2012 and was not statistically significantly different in an analysis of 94 participants (RR 0.07, 95% CI 0.00 to 1.17). Intention-to-treat (ITT) analyses of non-adherence at six weeks (RR 0.02, 95% CI 0.00 to 0.36) and at six months (RR 0.01, 95% CI 0.00 to 0.16) however, were statistically significantly different and favoured the PEG group Analysis 1.2.

Subgroup analyses

We further subgrouped the studies by endoscopic gastrostomy technique into pull (n = 90), push (n = 33), and not reported (n = 285) in Analysis 1.3. We observed a significant difference favouring PEG in the pull subgroup (RR 0.07, 95% CI 0.01 to 0.35, three studies, P = 0.001). Thepush subgroup contained only one clinical trial and the result favoured PEG (RR 0.05, 95% CI 0.00 to 0.74, P = 0.03) techniques. We found no statistically significant difference in cases where technique was not reported (RR 0.43, 95% CI 0.13 to 1.44). Statistically significant heterogeneity was found in the unreported technique subgroup (I² statistic = 73%), and the statistical significance of this result was unchanged in ITT analyses (RR 0.37, 95% CI 0.09 to 1.45) Analysis 1.5.1.

We made a post-hoc decision to investigate the possible reasons for this heterogeneity in Analysis 1.4 using subgroup analysis. Therefore we subgrouped the studies by participant condition (Analysis 1.4). For participants with cerebrovascular events or neurological baseline diseases (n = 109), the result favoured the PEG group (RR 0.08, 95% CI 0.02 to 0.33, P = 0.0005). There was no statistical heterogeneity in this analysis. For participants with mixed baseline diseases (n = 299), the intervention favoured neither PEG nor NGT(RR 0.32, 95% CI 0.08 to 1.32), and statistical heterogeneity was high (I2 = 79%), The statistical non-significance of this result, was unchanged in ITT analyses (RR 0.29, 95% CI 0.06 to 1.33; Analysis 1.5.2).

Secondary outcomes

Mortality

The outcome of mortality was examined in nine studies (Baeten 1992; Bath 1997; Corry 2008; Dennis 2005; Douzinas 2006; Elbadawy 2014; Hamidon 2006; Norton 1996; Park 1992) (644 participants) and was assessed independently of study follow-up time. The results showed 35.76% (118 out of 330 participants) in the PEG group and 36.62% (115 out of 314 participants) in the NGT group (RR 0.86, 95% CI 0.58 to 1.28) (Mantel-Haenszels statistical method). The result of the meta-analysis for mortality revealed no statistically significant difference between comparison groups. Finally, we observed statistical heterogeneity between included studies: I² statistic = 47%. Because of the radiologically placed gastrostomy technique used in a small number of participants in Dennis 2005, we carried out a sensitivity analysis to test the differences in the estimate effects by including and excluding this study. The sensitivity analysis shows that the inclusion of the FOOD study (Dennis 2005) did not change the statistical significance of the result for mortality (RR 0.81 (95% CI 0.47 to 1.41, P = 0.84; Analysis 1.6) without Dennis 2005 (analysis not shown).

One study (n = 82) reported the mean survival time in months (Yata 2001) (MD 4.3, 95% CI 3.28 to 5.32; Analysis 1.7). The result favoured the PEG group, that is participants in the PEG group survived longer, for a mean of 11.4 months compared with 7.1 months in the NGT group.

Complications and adverse effects

Complications and adverse effects (e.g., aspiration, haemorrhage, wound infection, sinusitis, fistula) were examined in six studies (Baeten 1992; Corry 2008; Dennis 2005; Douzinas 2006; Norton 1996; Sadasivan 2012) (597 participants) and was assessed independently of study follow-up time or severity of adverse effect. Although some of adverse events were characteristic of only one intervention, we analysed them together for the purposes of this review. The results showed 35.67% (107 out of 300 participants) in the PEG group and 45.79% (136 out of 297 participants) in the NGT group had adverse effects (RR 0.83, 95% CI 0.51 to 1.34; Analysis 1.8) (Mantel-Haenszel's statistical method). The result of the meta-analysis for adverse effects revealed no statistically significant difference between the groups. We observed high statistical heterogeneity in the comparison: I² statistic = 87%. An ITT analysis of these data did not change the statistical significance of the result (RR 0.81, 95% CI 0.48 to 1.35; Analysis 1.9)

In Elbadawy 2014, which was a study of critically ill participants who had experienced head injury, adverse events associated with PEG tracheostomy and nasogastric tube were reported. Adverse events were reported as number of events, rather than number of participants experiencing adverse events (that is, participants may have experienced more than one type of adverse event). In this study, the adverse events in the PEG group were infection in the gastrostomy tube in 19 participants, leakage around the gastrostomy tube in 21 participants, dislodgement of the gastrostomy tube in 19 and obstruction of the PEG tube in two participants. Fistulas, perforations and 'buried pumper' syndrome (where the PEG tube migrates) were not seen. In the NGT group, paranasal sinusitis from the nasogastric tube was found in 12 participants (60%) (Table 2).

Table 2. Additional data of adverse events
  1. P1 is the comparison between group I and group II

    P2 is the comparison between group I and group III

    P3 is comparison between group II and group III

Adverse events from Elbadawy 2014 Group I
(NGT + intubation)
Group II
(PEG + intubation)
Group III
(PEG + tracheostomy)
P1 P2 P3
No. % No. % No. %
Infection of tracheostomy wound00.000.01680.00---
Bleeding from tracheostomy00.000.000.00---
Pneumothorax00.000.0315.00---
Tracheo-oesophageal fistula00.000.0525.00---
Infection of gastrostomy wound00.01050.00945.00--0.635
Leakage around gastrostomy tube00.01155.001050--0.732
Dislodgement of gastrostomy tube00.01050.00945.00--0.751
GIT Fistula00.000.0000.00---
GIT Perforation00.000.0000.00---
Buried Pumper syndrome00.000.0000.00---
Obstruction00.015.0010.00--0.742
Paransal sinusitis1260.000.000.0---
Aspriration (pneumonia)

The outcome of pneumonia (as a result of aspiration) was examined in seven studies (Baeten 1992; Corry 2008; Dennis 2005; Douzinas 2006; Elbadawy 2014; Norton 1996; Yata 2001) (645 participants) and was assessed independently of study follow-up time. The results showed 31.93% (106 out of 332 participants) pneumonia in the PEG group and 41.54% (130 out of 313 participants) in the NGT group (RR 0.70, 95% CI 0.46 to 1.06; Analysis 1.10). However, the result of the meta-analysis for the pneumonia outcome did not favour PEG. We observed high levels of statistical heterogeneity between studies: I² statistic = 81%.

Reflux oesophagitis

Douzinas 2006 reported median change in gastro-oesophageal reflux at endpoint (day seven) as percentage of the time when the oesophageal pH was less than 4 in a given 24-hour period of time. The percentage was statistically significant, that is, less severe reflux was seen in the PEG group.

Yata 2001 reported reflux oesophagitis. In this single study analysis of 82 patients in total, there was a statistically significant result that favoured the PEG group (RR 0.45, 95% CI 0.22 to 0.92; Analysis 1.11).

Nutritional status

We analysed data for nutritional status, as measured by any validated instrument (e.g. as upper-arm skin fold thickness, mid-arm circumference, body weight, serum albumin level, haemoglobin)

Weight

In a single study analysis of weight (kg) at the study endpoint (Norton 1996) (mean difference (MD) 3.20, 95% CI -5.95 to 12.35; Analysis 1.12) The outcome favoured neither NGT or PEG. Three studies contributed to an analysis of weight change from baseline (n = 148, Corry 2008; Norton 1996; Sadasivan 2012) (MD 3.11, 95% CI -0.52 to 6.75; Analysis 1.13), that is, the outcome favoured neither NGT or PEG. In this analysis statistical heterogeneity was high I2 = 93%.

Mid-arm circumference

Norton 1996 reported mid-arm circumference in centimetres at the end point of the study and the change from baseline. The published report of Corry 2008 provided upper-arm circumference data for the NGT and PEG group as the median 300 mm (range 240 to 352) verus PEG 302.5, P= 0.69 (range 270 to 370) (mean 283 mm versus 295 mm respectively, P=0.25, not statistically significant, no standard deviations (SDs) reported Table 1). We calculated the missing SD values for the data from Corry 2008 and the result for a meta-analysis of both studies (n = 54) for arm circumference favoured neither intervention or control (MD 1.58, 95% CI -0.11 to 3.27; Analysis 1.14). No statistical heterogeneity was observed in this analysis I2 = 0%. This overall result was unchanged in a sensitivity analysis (MD 2.50, 95% CI -0.64 to 5.64; Analysis 1.14.2)

The change in mid-arm circumference from baseline was measured in Norton 1996 and Sadasivan 2012. In this analysis of 115 participants, the results were statistically significant in favour of PEG (MD 1.16, 95% CI 1.01 to 1.31; Analysis 1.15).

The included studies also reported anthropometric outcome data as median values which we could not include in our meta-analyses (Table 1). Median triceps skin fold thickness was reported in Corry 2008 and Hamidon 2006 and these were not significantly different in either study, however in Corry 2008, the study reports states that the NGT patients had significantly lower triceps skin fold thickness (mean 9.5 versus 13.5 mm; P = 0.03 than the PEG patients at six weeks post-treatment). Median biceps skin fold (mm) and median arm circumference was reported in Hamidon 2006 (Table 1) and the differences between groups were not statistically significantly different in either case.

Serum albumin

Mean serum albumin levels (g/dL) were reported in Yata 2001 and Norton 1996.

Yata 2001 was a short conference report and did not include SD values but reported that the serum albumin levels at three and six months were significantly different in the study report of Yata 2001 favouring PEG (P = <0.01) (Table 1). We calculated SD for this study using the difference between means and in an analysis of albumin levels of two studies of 107 participants, the result was statistically significant favouring the PEG group (MD 6.03, 95% CI 2.31 to 9.74; P = 0.001). Statistical heterogeneity was high I2 = 75%. In a sensitivity analysis excluding Yata 2001, the result remained statistically significant, that is, using data only from Norton 1996, an analysis of albumin levels at endpoint in 25 participants indicated a statistically significant result in favour of PEG (MD 7.80, 95% CI 5.52 to 10.08; Analysis 1.16).

Sadasivan 2012 reported change in albumin levels from baseline and again this result was statistically significant in an analysis of 94 participants favouring PEG (MD 0.12, 95% CI 0.11 to 0.14; Analysis 1.17).

The median serum albumin endpoint values were lower in the NGT group in Hamidon 2006 (P = 0.054) (Table 1).

Hamidon 2006 also reported nutritional status outcome data as median values which we could not include in our meta-analyses (Table 1). Median serum albumin (g/L) was 39.5 (R 36 to 44) in the PEG groups versus 36.0 (R 31 to 45) in the NGT group. The P value was 0.045, which was statistically significantly different .

Haemoglobin

Haemoglobin levels were reported as a change from baseline in Sadasivan 2012, In this single study analysis of 94 participants, the results favoured PEG and was statistically significant (MD 0.59, 95% CI 0.49 to 0.69; Analysis 1.18).

Yata 2001 reported that mean haemoglobin levels (g/L) were 11.7 in the NG group and in the PEG group were 11.9 at three months, and 11.1 versus 12.4 at six months (Table 1).

Time of enteral nutrition

Two studies (n = 119) reported the duration of enteral feeding in days (Baeten 1992; Park 1992) (MD 14.48, 95% CI -2.74 to 31.71; Analysis 1.21), this favoured neither NGT nor PGT and there were high levels of statistical heterogeneity present in this analysis (I² = 94%). These results should be interpreted cautiously as the assumption of normality for these outcomes may not be met.

Length of hospital stay

Two studies (n= 381) reported the length of hospital stay in days (Dennis 2005; Elbadawy 2014) (MD -12.67, 95% CI -40.18 to 14.84; Analysis 1.24), this favoured neither NGT nor PGT. There were high levels of statistical heterogeneity present in this analysis (I² = 93%). These results should be interpreted cautiously as the assumption of normality for these outcomes may not be met.

Quality of life
Patient satisfaction

Patient satisfaction was reported in Baeten 1992 (a five-point graded scale graded from 1 = very satisfied to 5 = very dissatisfied). In an analysis of 43 participants, the result favoured neither PEG nor NGT (MD -0.56, 95% CI -1.32 to 0.20) (Analysis 1.19). The inconvenience score (that is, inconvenience of maintaining the intervention to nursing staff in a scale with five categories) was also a statistically non-significantly different in an analysis of 68 patients in Baeten 1992 (MD -0.58, 95% CI -1.18 to 0.02; Analysis 1.20).

Quality-of-life was measured in two studies (Corry 2008; Sadasivan 2012) and included in a meta-analysis (Analysis 1.22), Using the EORTC QLQ-H & N 35 Scale, and the number of participants who scored three or four (in this scale a high score is a worse outcome), the outcomes of pain, in an analysis of 133 participants, (RR 0.33, 95% CI 0.00 to 471.74) and ease of learning to use (RR 0.18, 95% CI 0.00 to 149.53), there was no statistically significant difference between the PEG and the NGT group. In analyses of 133 participants each for the outcomes of inconvenience (RR 0.03, 95% CI 0.00 to 0.29; P=0.002) and discomfort (RR 0.03, 95% CI 0.00 to 0.29; P = 0.002), altered body image (RR 0.01, 95% CI 0.00 to 0.18; P = 0.001), and social activities (RR 0.01, 95% CI 0.00 to 0.18; n= 100, P = 0.001), the intervention favoured PEG, that is, fewer participants found the intervention of PEG to be inconvenient, uncomfortable or interfered with family life or social activities, and this was a statistically significantly different between the groups. There was statistical heterogeneity present in the analysis of pain (I² = 95%) and ease of learning to use (I² = 94%), and low levels of statistical heterogeneity in the analyses of inconvenience and discomfort (I² = 21%).

The outcome of family life could not be entered into a meta-analysis as Corry 2008 did not report this subscale. Using data from Sadasivan 2012 only, this outcome favoured the PEG group and this was a statistically significantly different (RR 0.01, 95% CI 0.00 to 0.18; n=100, P = 0.001).

Dennis 2005 reported the mean difference between comparison groups at endpoint derived from the EuroQol (reported as 0.035 95% CI -0.024 to 0.093). We could not include these data in our meta-analyses, but the report of the study states that the results were not statistically significantly different.

Functional ability

A decline in functional ability while under treatment may be related to overall quality of life. Functional ability is the ability to perform basic activities of daily life without support, an important aspect of overall independence and quality of life. Just one study reported functional ability by using a modified Rankin Scale (MRS) (Dennis 2005). There was no statistically significant difference between comparison groups (Analysis 1.23) for the following ranges of Modified Rankin Scales (MRS): MRS 0 to 3 (RR 0.59, 95% CI 0.34 to 1.01, P = 0.06) and MRS 4 to 5 (RR 1.20, 95% CI 0.90 to 1.61, P = 0.21) and for the outcome composed by MRS scales from 4 to 5 or death as showed by the RR of 1.10, 95% CI 1.00 to 1.20, P = 0.05).

Costs and economic issues

Only one study provided information about costs and we did not include these data in any analyses. Corry 2008 stated that the "cost of each feeding tube is $26 for a NGT and $110 for a PEG tube" and "The insertion costs are significantly different as the NGT are inserted by nursing staff in outpatients and the PEG tubes are inserted by surgeons in theatre. The cost for insertion of a NGT is $50 (includes nursing time and cost of chest X-ray), whereas the cost of insertion of a PEG tube is $626".

Discussion

Summary of main results

This systematic review of 11 included studies comprising 735 randomised participants in total (373 receiving percutaneous endoscopic gastrostomy (PEG) and 362 nasogastric tube (NGT)), produced 16 meta-analyses in total, for the primary outcome of intervention failure (subgrouped by gastrostomy technique and by baseline disease) and for the secondary outcomes of mortality, adverse effects in total and also pneumonia as a result of aspiration, nutritional status including weight change from baseline, mid-arm circumference at endpoint and change from baseline, time of enteral nutrition in days, length of stay in days, and quality of life measured by the EuroQol scale.

In our meta-analyses, overall, the estimated effects for the primary outcome of intervention failure showed a statistically significant lower risk in the PEG group compared with the NGT group, and this was confirmed in subgroup analyses of intervention failure for both the 'push' and 'pull' gastrostomy techniques (subgroup analysis of those studies which did not report the gastrostomy technique showed no statistically significant difference between PEG or NGT). However, we cannot infer from the effect sizes that one technique (push or pull) is superior to the other as we did not carry out comparisons (indirect analysis) of the different techniques using data from separate studies.

We carried out additional intention-to-treat (ITT) analyses for the outcome of intervention failure specifically for the four studies with participants with mixed baseline diseases, and for intervention failure in the four studies where the gastrostomy technique was not reported, and we found no statistically significant differences between the PEG and NGT groups.

No direct causal relationship with the procedures was established for the secondary outcome of mortality i.e. there was no statistically significant difference between PEG or NGT for this outcomes. Only Dennis 2005 and Baeten 1992 reported a relationship between procedure-related mortality and global mortality, ranging from 0% to 10%. These low rates support the notion that the use of these methods may have no significant influence on risk of death.

Meta-anaysis of adverse effects irrespective of follow-up time showed no statistically significant differences between the groups, and an ITT analysis of five studies for this outcome showed no statistically significant differences between the PEG and NGT groups. Fewer participants in the PEG group experienced pneumonia, an adverse event precipitated by aspiration of stomach contents or oro-pharyngeal secretions into the airway, but this difference was not statistically significant.

The meta-analyses of the secondary outcome of nutritional status i.e. weight change from baseline showed no statistically significant difference between the groups; endpoint mid-arm circumference was not statistically significantly different between the groups, although the outcome of mid-arm circumference in centimetres (change from baseline) was statistically significant in favour of PEG.

The meta-analysis of quality-of-life measures (a secondary outcome) was statistically significant favouring PEG (that is, more patients in the NGT group reported worse outcomes) for the outcomes of inconvenience, discomfort, altered or bad body image, social activities and in a single study analysis, interference with family life.

We also present analyses of data from single studies for the primary outcome of intervention failure that is non-adherence to treatment, and the secondary outcomes of adverse effects (specifically reflux oesophagitis), nutritional status including weight at endpoint, serum albumin levels and change from baseline, changes in haemoglobin levels g/dL from baseline, and measures of quality of life including scores of patient satisfaction and of inconvenience in maintaining the PEG or NGT by nurses, participant functional ability, and impact on family life measured by the EORTCQLQ-H&N35 (in one study).The single study analyses of the primary outcome non-adherence to treatment was statistically significant in favour of the PEG group at the six-week and six-month follow-up point in Sadasivan 2012 and notably all the dropouts from treatment were from the NGT group in that study (at six months there were no patients in the NGT group due to resumption of oral feeds (n = 10) or conversion to a PEG tube (n = 34).

For the secondary outcome of adverse effects, fewer patients in the Yata 2001 study reported reflux oesophagitis in the PEG group and this was statistically significant favouring PEG. For the secondary outcome of nutritional status, the mean participant body weight in kilograms at the endpoint, showed no statistically significant difference favouring PEG or NGT. Serum albumin levels at endpoint were statistically significant in Norton 1996, favouring the PEG group and also the serum albumin change from baseline were statistically significant favouring PEG in Sadasivan 2012. Haemoglobin levels expressed as a change from baseline also were higher in the PEG group and this was a statistically significant in the only study that reported this outcome (Sadasivan 2012).

Outcomes relating to quality of life, including the scores of patient satisfaction and inconvenience in maintaining the intervention by nurses as reported in Baeten 1992, were not statistically significant in favour of either PEG or NGT. Functional ability reported in Dennis 2005 favoured neither PEG nor NGT.

Analyses of time on enteral nutrition and length of hospital stay favoured neither PEG nor NGT. However, these analyses of time are very unlikely to follow a normal distribution, so the analyses of mean differences are not necessarily accurate.These results should be interpreted cautiously as the assumption of normality for these outcomes may not be met.

These conclusions were not changed by the 2014 update of the review.

Overall completeness and applicability of evidence

Based on the findings of this review, outcomes in participants who received nutritional support via a PEG may be more favourable that in those who have a NGT, especially for the outcome of intervention failure, based on an examination of 408 participants who had heterogeneous clinical and demographic characteristics.

Participants receiving PEG may be more likely to adhere to treatment at six weeks and six months. However, we found no evidence of a difference in mortality or adverse events (aspiration pneumonia) between the comparison groups. This non significant result does not imply no difference and we suggest that the review may not have had sufficient power to look at these less common events. Participants receiving PEG may experience less reflux oesophagitis (an adverse event). There is limited evidence, derived from single study results and small meta-analyses that PEG results in better outcomes in terms participants' nutritional status (mid-arm circumference, haemoglobin levels and serum albumin), and report better quality of life.

We found clinical heterogeneity between the studies and noted statistical heterogeneity in some of our analyses. For example, for our analyses of intervention failure, our primary outcome, we observed high levels of statistical heterogeneity resulting from the inclusion of the Baeten 1992 and Yata 2001 trials. One explanation for this may be the clinical heterogeneity between the trials, with the participants having different baseline diseases. We made a post-hoc decision to investigate the possible reasons for heterogeneity in the intervention failure meta-analysis as we assumed that the source of this statistical heterogeneity would be related to clinical heterogeneity. We hypothesised that baseline disease may have contributed to clinical heterogeneity and we categorised the studies by baseline disease, i.e. cerebrovascular event or neurological disorder versus mixed baseline disease (i.e. participants who may have had severe co-morbidities including cancer) and found that for the outcome of intervention failures in participants with cerebrovascular or neurological disease only, the results favoured PEG (i.e. fewer participants in the PEG group experienced any of the adverse events evaluated in the studies), but there was no difference between the groups for the mixed baseline disease subgroups and these studies included Baeten 1992 and Yata 2001. However, our hypothesis and the results of this analysis only point to one possible cause of heterogeneity, and this should be adequately tested in future studies. One further source of clinical heterogeneity in the remaining analyses could be because of the different techniques used to insert the PEG.

Many of the studies reported continuous outcome data in a format that could not be incorporated in to our meta-analyses for example, median values. This limited the number of analyses that we could perform and we reported these data narratively in the review. Information reported in this way should be regarded as providing additional information only and the analyses we performed including meta-analysis, forest plots, tests for statistical heterogeneity provide more precise estimates of effects.

Quality of the evidence

The findings of the present review of the literature should be interpreted with caution, given that almost half of the authors failed to report the method used to sequence and conceal the allocation (Figure 2; Figure 3). This is one of the main causes of error in randomised systematic studies. In addition, other potential risks of bias stemmed from the absence of prior planning of follow-up time, as well as the unpublished or high rates of losses during follow-up. However, almost all of the authors attempted to prevent attrition by making the flow of patients clear and through selective reporting bias by selecting clinically relevant outcomes. There are also challenges relating to the study design in terms of the numbers available for randomisation, following up such seriously ill patients and the high cost of the procedures in question. These factors may explain why the majority of studies involve small samples. It should be noted that all of the studies were judged at high risk of performance bias because it is not possible to blind participants and personnel in studies of this nature. In all cases of uncertainly we attempted to obtain further information or disaggregated data from the trial investigator, but where this was not available it was because the investigator no longer had access to historical trial data, or was unable to provide additional information. This systematic review of the literature is valuable in analysing 11 studies, thereby increasing the sample size to 735 participants. Nevertheless, further randomised clinical trials that adopt a rigorous method are warranted.

We rated the overall quality of the evidence as moderate or low for the key outcomes of treatment failure, mortality, pneumonia and adverse events (Summary of findings for the main comparison), resulting in lower confidence in the estimate of effect for those outcomes and further research is likely to have an important impact in our confidence in the estimate of effect and may even change the estimate. Where we downgraded the evidence, it was because there was risk of bias in the trial, out of eight estimates of potential bias (random sequence generation; allocation concealment; incomplete outcome data; selective reporting; blinding of participants and personnel; blinding of outcome assessment, and other bias) only six studies obtained scores of four or more. The included studies involved relatively few participants and wide confidence intervals (imprecision), although it is accepted that large scale studies of this type would be very difficult to perform. The results of many meta-analyses had high levels of statistical heterogeneity (inconsistency).

Potential biases in the review process

In view of the sensitive search strategy involving electronic correspondence with the eminent authors in this area of research, we believe that it is highly unlikely that other studies meeting the inclusion criteria of this systematic review were overlooked, however this remains a possibility and could be regarded as a limitation of this review.

While we included adverse effects reported in the studies included in this the review, we may not have detected reports of all of serious and/or rare adverse events associated with PEG or NGT, and in common with many systematic review and meta-analyses, this is a could be limitation of this review.

As outlined, all efforts were made to ensure that relevant qualitative or quantitative data were included in this review.

Agreements and disagreements with other studies or reviews

In one of the major controlled randomised trials performed to date (Dennis 2005), the authors suggested that NGT should be the method of choice in the first two to three weeks of enteral feeding, probably in light of the increased absolute risk of death associated with the use of PEG (RR 1.02, P = 0.86) and the absolute risk of the outcome composed by MRS scale (modified Rankin scale) from four to five or death (RR 1.10, P = 0.05). However, combining the results of 11 different studies with ≅ 400 patients, it seems that the PEG option is associated with a lower risk of intervention failure. Given the importance of this finding, selecting PEG might reduce the difference in cost between the two procedures. The findings of all of the other studies included in this analysis seem to support the use of PEG. Guidelines suggest that PEG is a highly effective and safe procedure when modern equipment is used, established standards are followed (Löser 2005). However, a careful patient selection and professional proficiency are fundamental for better outcomes (Blumenstein 2014; Skitt 2011). In a narrative review, Plonk 2005 suggested that the use of PEG should only be considered in amyotrophic lateral sclerosis, intestinal blockage by malignant tumour with incoercible vomiting, persistent dysphagia after acute stroke, and early head and neck cancer. However, the results of a systematic review that included studies with different designs suggests that PEG and NGT have the same effectiveness and safety for patients with head and neck cancer, even considering relevant outcomes, such as mortality and nutritional status (Wang 2014). Although no study included in our systematic review made available information about the use of nasal looping technique, there is some evidence that such NGT technique has potential to be preferable over PEG (Anderson 2004).

Authors' conclusions

Implications for practice

Based on the findings of this meta-analysis, the results favoured PEG rather than NGT for intervention failure, but not for mortality and pneumonia rates, and other adverse events. There may be some advantage in terms of nutritional status in using PEG over NGT, and patients may report better quality of life when using a PEG tube.

In routine practice, however, the costs and benefits of both procedures should be taken into account. Some health service providers, particularly under the public health system, face difficulties acquiring endoscopic gastrostomy apparatus due to their high cost. Possible reasons for the current state of the research in this area include the high cost of the procedures in question. Corry 2008 provided an example of this stating that the "cost of each feeding tube is $26 for a NGT and $110 for a PEG tube" However, it is noteworthy that because nasogastric tubes are easier to introduce (more often by the nursing team) and less weight is placed on the cost of constantly changing them as stated in Corry 2008 "The insertion costs are significantly different as the NGT are inserted by nursing staff in outpatients and the PEG tubes are inserted by surgeons in theatre. The cost for insertion of a NGT is $50 (includes nursing time and cost of chest X-ray), whereas the cost of insertion of a PEG tube is $626". Therefore endoscopic gastrostomies may be less frequently indicated (Corry 2008).

It is important to note that in clinical practice, an endoscopic examination performed prior to PEG insertion is indicated in all cases, as the patient might present with lesions of the gastrointestinal tract, which prevents the passage of the endoscopy device and even tubes. In such patients, gastric tumours might also be present, which precludes gastrostomy. Partial gastric resections can also influence patients to elect to use alternative methods of enteral feeding.

Implications for research

Our systematic review of the current evidence, carried out in 2014, indicated that information is available on important outcomes such as intervention failure, mortality, pneumonia and adverse events. The included studies were carried out with participants with varying baseline diseases including neurological baseline diseases and those with malignancies. Future studies should provide adequate baseline information such as baseline disease, gender and age of the participants. The gastrostomy technique was described only in some of the included studies, and future researchers should ideally specify the technique used and the experience of the professionals involved to allow for the analysis of more specific subgroups. Data on the nutritional status of the patients would prove valuable, as would a cost/benefit analysis of the number of feeding tubes used. Quality-of-life measures provide useful information about patient important outcomes and may help explain differences in adherence to treatment.

The high cost of the procedures in question combined with the difficulties associated with the randomisation and long-term follow-up of patients and explain why the majority of studies examine a small number of participants. Nevertheless, we believe that further randomised clinical trials should be conducted with rigorous observation of internal validity. They should also include previously planned and executed follow-up periods.

Acknowledgements

We would like to thank the methodological support of the Brazilian Cochrane Centre and the CAPES (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior) - Brazilian Ministry of Education for the scholarship.

We thank the Cochrane UGPD group for their support in the preparation of this updated review.

Data and analyses

Download statistical data

Comparison 1. PEG versus NGT
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Intervention failure8408Risk Ratio (M-H, Random, 95% CI)0.18 [0.05, 0.59]
1.1 All baseline diseases8408Risk Ratio (M-H, Random, 95% CI)0.18 [0.05, 0.59]
2 Non adherence to treatment1 Risk Ratio (M-H, Random, 95% CI)Subtotals only
2.1 Non adherence at 6 weeks194Risk Ratio (M-H, Random, 95% CI)0.07 [0.00, 1.17]
2.2 ITT non adherence at 6 weeks1100Risk Ratio (M-H, Random, 95% CI)0.02 [0.00, 0.36]
2.3 ITT non adherence at 6 months1100Risk Ratio (M-H, Random, 95% CI)0.01 [0.00, 0.16]
3 Intervention failure (subgrouped by gastrostomy technique)8408Risk Ratio (M-H, Random, 95% CI)0.18 [0.05, 0.59]
3.1 Pull technique390Risk Ratio (M-H, Random, 95% CI)0.07 [0.01, 0.35]
3.2 Push technique133Risk Ratio (M-H, Random, 95% CI)0.05 [0.00, 0.74]
3.3 Non-reported technique4285Risk Ratio (M-H, Random, 95% CI)0.43 [0.13, 1.44]
4 Intervention failure (subgrouped by baseline disease)8408Risk Ratio (M-H, Random, 95% CI)0.18 [0.05, 0.59]
4.1 Cerebrovascular event or neurological baseline diseases4109Risk Ratio (M-H, Random, 95% CI)0.08 [0.02, 0.33]
4.2 Mixed baseline diseases4299Risk Ratio (M-H, Random, 95% CI)0.32 [0.08, 1.32]
5 ITT analyses5 Risk Ratio (M-H, Random, 95% CI)Subtotals only
5.1 ITT intervention failure non-reported gastrostomy technique4285Risk Ratio (M-H, Random, 95% CI)0.37 [0.09, 1.45]
5.2 ITT intervention failure mixed baseline diseases4305Risk Ratio (M-H, Random, 95% CI)0.29 [0.06, 1.33]
6 Mortality irrespective of follow-up time9644Risk Ratio (M-H, Random, 95% CI)0.86 [0.58, 1.28]
7 Mean survival (months)182Mean Difference (IV, Random, 95% CI)4.30 [3.28, 5.32]
8 Adverse effects irrespective of follow-up time6597Risk Ratio (M-H, Random, 95% CI)0.83 [0.51, 1.34]
8.1 Adverse effects6597Risk Ratio (M-H, Random, 95% CI)0.83 [0.51, 1.34]
9 Adverse effects irrespective of follow-up time6603Risk Ratio (M-H, Random, 95% CI)0.81 [0.48, 1.35]
9.1 ITT adverse effects irrespective of follow-up time6603Risk Ratio (M-H, Random, 95% CI)0.81 [0.48, 1.35]
10 Pneumonia irrespective of follow-up time7645Risk Ratio (M-H, Random, 95% CI)0.70 [0.46, 1.06]
11 Reflux oesophagitis182Risk Ratio (M-H, Random, 95% CI)0.45 [0.22, 0.92]
12 Weight kg (endpoint)121Mean Difference (IV, Random, 95% CI)3.20 [-5.95, 12.35]
13 Weight (change from baseline)3148Mean Difference (IV, Random, 95% CI)3.11 [-0.52, 6.75]
14 Mid-arm circumference in cm (endpoint)2 Mean Difference (IV, Random, 95% CI)Subtotals only
14.1 Mid-arm circumference254Mean Difference (IV, Random, 95% CI)1.58 [-0.11, 3.27]
14.2 Sensitivity analysis121Mean Difference (IV, Random, 95% CI)2.5 [-0.64, 5.64]
15 Mid-arm circumference in cm (change from baseline)2115Mean Difference (IV, Random, 95% CI)1.16 [1.01, 1.31]
16 Albumin2 Mean Difference (IV, Random, 95% CI)Subtotals only
16.1 Mean serum albumin levels2107Mean Difference (IV, Random, 95% CI)6.03 [2.31, 9.74]
16.2 Sensitivity analysis125Mean Difference (IV, Random, 95% CI)7.80 [5.52, 10.08]
17 Albumin (change from baseline)194Mean Difference (IV, Random, 95% CI)0.12 [0.11, 0.14]
18 Haemoglobin g/dL (change from baseline)194Mean Difference (IV, Random, 95% CI)0.59 [0.49, 0.69]
19 Score of patients satisfaction143Mean Difference (IV, Random, 95% CI)-0.56 [-1.32, 0.20]
20 Score of inconvenience by nurses168Mean Difference (IV, Random, 95% CI)-0.58 [-1.18, 0.02]
21 Time on enteral nutrition (days)2119Mean Difference (IV, Random, 95% CI)14.48 [-2.74, 31.71]
22 Quality of life measures EORTC QLQ-H&N35 number scoring 3 or 4 (worst)2 Risk Ratio (M-H, Random, 95% CI)Subtotals only
22.1 Pain2133Risk Ratio (M-H, Random, 95% CI)0.33 [0.00, 471.74]
22.2 Learning to use2133Risk Ratio (M-H, Random, 95% CI)0.18 [0.00, 149.53]
22.3 Inconvenient2133Risk Ratio (M-H, Random, 95% CI)0.03 [0.00, 0.29]
22.4 Uncomfortable2133Risk Ratio (M-H, Random, 95% CI)0.03 [0.00, 0.29]
22.5 Altered/bad body image2133Risk Ratio (M-H, Random, 95% CI)0.01 [0.00, 0.18]
22.6 Family life1100Risk Ratio (M-H, Random, 95% CI)0.01 [0.00, 0.18]
22.7 Social activities2133Risk Ratio (M-H, Random, 95% CI)0.01 [0.00, 0.18]
23 Functional ability (MRS)1 Risk Ratio (M-H, Random, 95% CI)Subtotals only
23.1 MRS scale from 0-31321Risk Ratio (M-H, Random, 95% CI)0.59 [0.34, 1.01]
23.2 MRS scale from 4-51321Risk Ratio (M-H, Random, 95% CI)1.20 [0.90, 1.61]
23.3 MRS scale from 4-5 or death1321Risk Ratio (M-H, Random, 95% CI)1.10 [1.00, 1.20]
24 Length of hospital stay (days)2381Mean Difference (IV, Random, 95% CI)-12.67 [-40.18, 14.84]
Analysis 1.1.

Comparison 1 PEG versus NGT, Outcome 1 Intervention failure.

Analysis 1.2.

Comparison 1 PEG versus NGT, Outcome 2 Non adherence to treatment.

Analysis 1.3.

Comparison 1 PEG versus NGT, Outcome 3 Intervention failure (subgrouped by gastrostomy technique).

Analysis 1.4.

Comparison 1 PEG versus NGT, Outcome 4 Intervention failure (subgrouped by baseline disease).

Analysis 1.5.

Comparison 1 PEG versus NGT, Outcome 5 ITT analyses.

Analysis 1.6.

Comparison 1 PEG versus NGT, Outcome 6 Mortality irrespective of follow-up time.

Analysis 1.7.

Comparison 1 PEG versus NGT, Outcome 7 Mean survival (months).

Analysis 1.8.

Comparison 1 PEG versus NGT, Outcome 8 Adverse effects irrespective of follow-up time.

Analysis 1.9.

Comparison 1 PEG versus NGT, Outcome 9 Adverse effects irrespective of follow-up time.

Analysis 1.10.

Comparison 1 PEG versus NGT, Outcome 10 Pneumonia irrespective of follow-up time.

Analysis 1.11.

Comparison 1 PEG versus NGT, Outcome 11 Reflux oesophagitis.

Analysis 1.12.

Comparison 1 PEG versus NGT, Outcome 12 Weight kg (endpoint).

Analysis 1.13.

Comparison 1 PEG versus NGT, Outcome 13 Weight (change from baseline).

Analysis 1.14.

Comparison 1 PEG versus NGT, Outcome 14 Mid-arm circumference in cm (endpoint).

Analysis 1.15.

Comparison 1 PEG versus NGT, Outcome 15 Mid-arm circumference in cm (change from baseline).

Analysis 1.16.

Comparison 1 PEG versus NGT, Outcome 16 Albumin.

Analysis 1.17.

Comparison 1 PEG versus NGT, Outcome 17 Albumin (change from baseline).

Analysis 1.18.

Comparison 1 PEG versus NGT, Outcome 18 Haemoglobin g/dL (change from baseline).

Analysis 1.19.

Comparison 1 PEG versus NGT, Outcome 19 Score of patients satisfaction.

Analysis 1.20.

Comparison 1 PEG versus NGT, Outcome 20 Score of inconvenience by nurses.

Analysis 1.21.

Comparison 1 PEG versus NGT, Outcome 21 Time on enteral nutrition (days).

Analysis 1.22.

Comparison 1 PEG versus NGT, Outcome 22 Quality of life measures EORTC QLQ-H&N35 number scoring 3 or 4 (worst).

Analysis 1.23.

Comparison 1 PEG versus NGT, Outcome 23 Functional ability (MRS).

Analysis 1.24.

Comparison 1 PEG versus NGT, Outcome 24 Length of hospital stay (days).

Appendices

Appendix 1. CENTRAL search strategy

  1. esophag*

  2. oesophag*

  3. 1 or 2

  4. disease*

  5. Neoplasms/

  6. cancer*

  7. Adenocarcinoma/

  8. or/4-7

  9. 3 and 8

  10. Pathologic Constriction

  11. stenosis

  12. stenoses

  13. dysmotilit*

  14. stricture

  15. or/10-14

  16. 3 and 15

  17. (Esophageal Motility Disorders) or (Esophageal Diverticulum) or (Esophageal Diverticulosis) or (Esophageal Stenosis) or (Esophageal Achalasia)

  18. Deglutition Disorders/

  19. dysphagia

  20. swallowing disorder*

  21. swallowing disturbance*

  22. Esophageal Diseases/

  23. or/16-22

  24. Enteral Nutrition/

  25. Gastrointestinal Intubation/

  26. tube feeding

  27. gastroenteral tube

  28. nasoenteral tube

  29. nasojejunal feeding tube

  30. nasojejunal tube

  31. enteral feeding

  32. gastric feeding tube*

  33. Feeding Apparatus/ or Nutritional Support/ or Enteric Feeding/ or Tube Feeding/

  34. force feeding*

  35. Nasogastric Tube/

  36. post-pyloric feeding

  37. postpyloric feeding

  38. Enteric Feeding/

  39. trans-pyloric feeding

  40. nasoduodenal tube

  41. Gastrointestinal Endoscopy/ or Digestive System Endoscopy/

  42. endoscop*

  43. Endoscopic Surgical Procedure*

  44. Gastrostom*

  45. Gastrostomy/

  46. percutaneous endoscopic gastrostomy

  47. or/24-46

  48. (9 or 23) and 47

Appendix 2. MEDLINE search strategy

  1. randomized controlled trial.pt.

  2. controlled clinical trial.pt.

  3. randomized.ab.

  4. placebo.ab.

  5. clinical trials as topic.sh.

  6. randomly.ab.

  7. trial.ti.

  8. or/1-7

  9. (animals not (humans and animals)).sh.

  10. 8 not 9

  11. esophag$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

  12. oesophag$.mp. [mp=title, original title, abstract, name of substance word, subject heading word]

  13. 11 or 12

  14. disease$.ab,ti.

  15. exp Neoplasms/

  16. cancer$.mp.

  17. exp Adenocarcinoma/

  18. or/14-17

  19. 13 and 18

  20. exp Constriction, Pathologic/

  21. stenosis.mp.

  22. stenoses.mp.

  23. dysmotilit$.mp.

  24. stricture.mp.

  25. or/20-24

  26. 13 and 25

  27. Esophageal Motility Disorders/ or Diverticulum, Esophageal/ or Diverticulosis, Esophageal/ or Esophageal Stenosis/ or Esophageal Achalasia/

  28. exp Deglutition Disorders/

  29. dysphagia.ab,ti.

  30. swallowing disorder$.ab,ti.

  31. swallowing disturbance$.ab,ti.

  32. Esophageal Diseases/

  33. or/26-32

  34. exp Enteral Nutrition/

  35. exp Intubation, Gastrointestinal/

  36. tube feeding.ab,ti.

  37. gastroenteral tube.ab,ti.

  38. nasoenteral tube.ab,ti.

  39. nasojejunal feeding tube.ab,ti.

  40. nasojejunal tube.ab,ti.

  41. enteral feeding.ab,ti.

  42. gastric feeding tube$.ab,ti.

  43. exp Feeding Apparatus/ or exp Nutritional Support/ or exp Enteric Feeding/ or exp Tube Feeding/

  44. force feeding$.ab,ti.

  45. Nasogastric Tube/

  46. post-pyloric feeding.ab,ti.

  47. postpyloric feeding.ab,ti.

  48. Enteric Feeding/

  49. trans-pyloric feeding.ab,ti.

  50. nasoduodenal tube.ab,ti.

  51. exp Endoscopy, Gastrointestinal/ or exp Endoscopy, Digestive System/

  52. endoscop$.ab,ti.

  53. Endoscopic Surgical Procedure$.mp.

  54. Gastrostom$.mp.

  55. exp Gastrostomy/

  56. percutaneous endoscopic gastrostomy.mp.

  57. or/34-56

  58. (19 or 33) and 57

  59. 10 and 58

Appendix 3. EMBASE search strategy

  1. (random$ or placebo$).ti,ab.

  2. ((single$ or double$ or triple$ or treble$) and (blind$ or mask$)).ti,ab.

  3. controlled clinical trial$.ti,ab.

  4. RETRACTED ARTICLE/

  5. or/1-4

  6. (animal$ not human$).sh,hw.

  7. 5 not 6

  8. esophag$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name]

  9. oesophag$.mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer name]

  10. 8 or 9

  11. disease$.ab,ti.

  12. exp Neoplasms/

  13. cancer$.mp.

  14. exp Adenocarcinoma/

  15. or/11-14

  16. 10 and 15

  17. exp Constriction, Pathologic/

  18. stenosis.mp.

  19. stenoses.mp.

  20. dysmotilit$.mp.

  21. stricture.mp.

  22. or/17-21

  23. 10 and 22

  24. Esophageal Motility Disorders/ or Diverticulum, Esophageal/ or Diverticulosis, Esophageal/ or Esophageal Stenosis/ or Esophageal Achalasia/

  25. exp Deglutition Disorders/

  26. dysphagia.ab,ti.

  27. swallowing disorder$.ab,ti.

  28. swallowing disturbance$.ab,ti.

  29. Esophageal Diseases/

  30. or/23-29

  31. exp Enteral Nutrition/

  32. exp Intubation, Gastrointestinal/

  33. tube feeding.ab,ti.

  34. gastroenteral tube.ab,ti.

  35. nasoenteral tube.ab,ti.

  36. nasojejunal feeding tube.ab,ti.

  37. nasojejunal tube.ab,ti.

  38. enteral feeding.ab,ti.

  39. gastric feeding tube$.ab,ti.

  40. exp Feeding Apparatus/ or exp Nutritional Support/ or exp Enteric Feeding/ or exp Tube Feeding/

  41. force feeding$.ab,ti.

  42. Nasogastric Tube/

  43. post-pyloric feeding.ab,ti.

  44. postpyloric feeding.ab,ti.

  45. Enteric Feeding/

  46. trans-pyloric feeding.ab,ti.

  47. nasoduodenal tube.ab,ti

  48. exp Endoscopy, Gastrointestinal/ or exp Endoscopy, Digestive System/

  49. endoscop$.ab,ti.

  50. Endoscopic Surgical Procedure$.mp.

  51. Gastrostom$.mp.

  52. exp Gastrostomy/

  53. percutaneous endoscopic gastrostomy.mp.

  54. or/31-53

  55. (16 or 30) and 54

  56. 7 and 5

Appendix 4. LILACS search strategy

  1. pt ensaio controlado aleatorio

  2. pt ensaio clinico controlado

  3. mh ensaios controlados aleatorios

  4. mh distribuicao aleatoria

  5. mh método duplo-cego

  6. mh método simples-cego

  7. pt estudo multicentrico

  8. #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7

  9. tw ensaio

  10. tw ensayo

  11. tw trial

  12. #9 OR #10 OR #11

  13. tw azar

  14. tw acaso

  15. tw placebo

  16. tw control$

  17. tw aleat$

  18. tw random$

  19. #13 OR #14 OR #15 OR #16 OR #17 OR #18

  20. tw duplo

  21. tw cego

  22. #20 AND #21

  23. tw doble

  24. tw ciego

  25. #23 AND #24

  26. tw double

  27. tw blind

  28. #26 AND #27

  29. #19 OR #22 OR #25 OR #28

  30. tw clinic$

  31. #12 AND #29 AND #30

  32. #8 OR #31

What's new

DateEventDescription
11 January 2017AmendedData in Table 1 from Yata 2001 corrected.

History

Protocol first published: Issue 4, 2009
Review first published: Issue 11, 2010

DateEventDescription
20 January 2015New citation required but conclusions have not changedUpdated with two new studies. Conclusions not changed.
20 January 2015New search has been performedNew review author (CB), updated with news studies and revised text to comply with current standards for systematic review reporting.
15 December 2011New citation required but conclusions have not changedNo new studies identified and conclusions unchanged.
15 December 2011New search has been performedLiterature searches rerun. No new studies identified and conclusions unchanged.
14 June 2011AmendedInformation about number of studies were amended in the Summary of Findings table and risk of bias terminology updated with no change to overall assessments.

Contributions of authors

Conceiving the review: CG, JW and DM
Co-ordinating the review: CG
Screening search results: CG and SL
Organising retrieval of papers: CG and DRW
Screening retrieved papers against inclusion criteria: CG, SL, DM and JW with CB
Apraising quality of papers: CG, SL, RBA and DRW with CB
Extracting data from papers: CG, DRW, SL and RBA with CB
Writing to authors of papers for additional information: CG with CB
Providing additional data about papers: CG with CB
Obtaining and screening data on unpublished studies: CG and DRW with CB
Data management for the review: CG and SL
Entering data into Review Manager (RevMan 5.0): CG and RBA, with CB
Other statistical analysis not using RevMan: RBA
Interpretation of data: CG,DM, SL,RBA and JW with CB
Statistical inferences: CG, RBA and SL
Writing the review: CG with CB

Person responsible for reading and checking review before submission: CG, DM, JW and SL

Declarations of interest

None known.

Dr Cathy Bennett is the proprietor of Systematic Research Ltd and received a consultancy fee from the Cochrane UGPD group to assist the authors with the update of their review in 2014.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • CAPES - Ministry of Education for the postgraduate scholarship, Brazil.

Differences between protocol and review

Previous criteria to evaluate the risk of bias are indicated below. The criteria were modified according to the new Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011)

Selection bias

  • Was the allocation sequence adequately generated?

  • Was allocation adequately concealed?

  • Were there systematic differences between the baseline characteristics of the groups that were compared?

Attrition bias

Were there systematic differences between groups in withdrawals from a study?

Detection bias

Were there systematic differences between groups in how outcomes were determined?

We included data in the analyses of scores of patient satisfaction and inconvenience to nursing staff from Baeten 1992, theses are five-point scales and it is unclear if these were validated scales.

In this update, for mean values of outcome data with missing standard deviations, we calculated this from the difference between means (Cochrane Handbook for Systematic Reviews of Interventions 7.7.3.3. Higgins 2011). We investigated the effects of making these assumptions by performing sensitivity analyses where appropriate.

Outcomes

We report outcomes as specified in the protocol and clarify the following: pneumonia in this instance occurs as a direct result of aspiration of food. Functional ability is included as an indicator of quality of life. Oesophageal reflux and reflux oesophagitis are adverse effects. We have included survival time as an additional outcome grouped with mortality.

Data synthesis

We planned to pool continuous data using SMD, but where the units of measurement were the same we used MD.

Subgroup analyses

We made a post-hoc decision to investigate the possible reasons for heterogeneity in the intervention failure meta-analysis as we assumed that the source of this statistical heterogeneity would be related to clinical heterogeneity. We categorised the studies by baseline disease, i.e. cerebrovascular event or neurological disorder versus mixed baseline disease (i.e. participants who may have had severe co-morbidities including cancer).

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Baeten 1992

Methods

Single-centre parallel randomised controlled trial

Setting: 1 hospital in the Netherlands

Sample size: not reported

Participants

Ninety patients with neurologic problems, ear, nose and throat tumours and surgical problems. 56 male, 34 female; mean age 72 (62 to 82)

Inclusion criteria: indication for enteral nutrition

Exclusion criteria: contra-indication for either method

Interventions

PEG (n = 44) - Freka set (Fresenius)

NGT (n = 46) -silicone tube 14 inch inserted by nurse

Outcomes
  1. Mortality

  2. Treatment failures

  3. Adverse events

  4. Pneumonia

  5. Patient convenience (5-point graded scale from 1 = very convenient to 5 = very inconvenient)

  6. Nurse convenience (5-point graded scale from 1 = very convenient to 5 = very inconvenient)

  7. Time for enteral nutrition (days)

  8. Time for insertion (minutes)

NotesFollow-up: mean nutrition time 17.9 ± 19.9 days
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Low riskSealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessors not blinded as explicitly referred by the authors
Incomplete outcome data (attrition bias)
All outcomes
Low riskThere were no withdrawals reported by the study investigators
Selective reporting (reporting bias)Low riskRelevant outcomes analysed
Other biasHigh riskFollow-up was not previously established

Bath 1997

Methods

Single-centre parallel randomised controlled trial

Setting: 1 hospital in UK

Sample size: not reported

Participants

Nineteen patients (8 male, 11 female); mean age: 77 years (11)

Baseline disease: 13 Ischaemic stroke, six haemorrhagic stroke

Inclusion criteria: stroke within two weeks of stroke onset

Exclusion criteria: oro-gastrointestinal disease concurrent severe illness, coagulopathy, pre-morbid dependency, severe dementia, psychiatric illness

Interventions

PEG: details not available

NGT: details not available

Outcomes

Primary outcomes

  1. Resumption of safe feeding at 12 weeks

  2. Weight loss < 5% at 6 weeks

  3. Discharge by 6 weeks

Secondary outcomes

  1. Impairment

  2. Disability

  3. Handicap

  4. Quality of life

  5. Tube failures

  6. Chest infection

  7. Oropharyngeal delay time at 4 weeks

Notes

Follow-up: three months

Risks of bias was judged from a systematic review previously published by the author (Bath 2009) and by email contact with the author

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated by minimisation
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot explicitly stated to be blinded by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Low riskIntention-to-treat analysis
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed
Other biasHigh riskUnpublished study

Corry 2008

Methods

Parallel randomised controlled trial

Setting: hospitals in Australia; enteral feeding on an outpatient basis

Sample size: the study planned to recruit 150 patients over two years, allowing a difference of at least 1.4 kg in mean weight loss to be detected between the two feeding tubes with 80% power using a two-sided test with significance level of 5%

Participants

42 patients; 24 male, 9 female; median age 60 (46 to 80)

Inclusion criteria: patients with squamous cell carcinoma of the head and neck planned for curative radiotherapy or chemoradiation who were anticipated to require enteral feeding

Exclusion criteria: refusal to be randomised and refusal to receive any tube for nutrition

Interventions

PEG (n = 22); push technique by Tucker (Kimberley-Clark MIC e Wilson-Cook)

NGT (n = 20); fine bore tube inserted by nurse and confirmed the correct placement by a chest X-ray and aspiration of stomach contents

All patients received enteral feeding at home

Outcomes
  1. Nutritional status (weight, upper-arm circumference, triceps skin fold thickness)

  2. Duration of enteral feeding

  3. Complication    

  4. Patient satisfaction (modified QoL questionnaire)

  5. Costs

All patients were assessed 6 months post-treatment

Notes

Nine patients did not receive the intervention to which they were allocated

Outcome four was not considered for analysis because the instrument of evaluation is not formally validated

Outcome one was not suitable for analysis because it was not explicitly informed if they were reported as means or medians

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskAdaptive biased coin technique
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcome assessors not blinded as explicitly referred by the authors
Incomplete outcome data (attrition bias)
All outcomes
Low riskFlow of patients was clearly reported
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed
Other biasLow riskNone suspected

Dennis 2005

Methods

Multicentric parallel randomised controlled trial

Setting: multicentric study involving many countries, mainly UK

Sample size: 1000 patients based on 85% power to detected and absolute risk difference for death or poor outcome of 9%. Type one error: 0.05

Participants

321 patients: 144 male, 177 female; mean age 76 (10); dysphagic stroke patients

Inclusion criteria: recent stroke (within 7 days before admission), first-ever or recurrent, if the responsible clinician was uncertain of the best feeding (PEG or NGT)

Exclusion criteria: patients with subarachnoid haemorrhage        

Interventions

PEG (n = 162)

NGT (n = 159)

Outcomes
  1. Mortality or poor outcome

  2. Overall survival

  3. Utility score (EUROQoL)

  4. Quality of life (EUROQoL)

  5. Length of hospital stay

  6. Adverse events in hospital stay

  7. Pneumonia

  8. Causes of death

  9. Treatment effect

  10. Number of tubes inserted

  11. Reasons for stopping feeding

  12. Vital status

  13. Functional ability (Modified Rankin scale)

  14. Clinicians' satisfaction about enteral feeding

  15. Time in enteral nutrition

Notes

Follow-up: six months

Outcomes 3, 10 and 13 were not suitable for analysis

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated, stratified by country, age, gender, and predicted probability of poor outcome (by minimisation)
Allocation concealment (selection bias)Low riskThe randomisation systems were housed on a secure server with access permitted, via a password. Participating centres were issued with codes in order for them to access the randomisation services (three separate numerical codes).
Blinding of participants and personnel (performance bias)
All outcomes
High riskAccording to the authors, "the randomising clinician, the clinical team, and the patients were not unaware to treatment allocation— doing so would have been impossible".
Blinding of outcome assessment (detection bias)
All outcomes
High risk

According to the authors, "the randomising clinician, the clinical team, and the patients were not unaware to treatment allocation— doing so would have been impossible". However, 6 month of follow-up was carried out for the following variables: patients’ vital status, functionalability with themodified Rankin score (MRS), 19 place of residence, method of feeding, and quality of life with the EUROQoL. For these variables, the authors referred that "follow-up was masked to treatment allocation (except where patients or carers inadvertently unmasked an interviewer at follow-up; such occurrences were unusual but their frequency was not systematically recorded)".

Because of these divergences the study was considered as of high risk of bias.

Incomplete outcome data (attrition bias)
All outcomes
Low riskFlow of patients was clearly reported
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed
Other biasLow riskNone suspected

Douzinas 2006

Methods

Single-centre parallel randomised controlled trial

Setting: 1 hospital (intensive care unit) in Greece

Sample size: not reported; pilot study was made

Participants

39 patients; 22 male, 14 female; median age: PEG 53 (20 to 82), NGT 58 (25 to 85).

Inclusion criteria: 1. patients on mechanical ventilation with NGT in place for more than 10 days, suffering from persistent or recurrent ventilator-associated pneumonia and reflux rate above 6%.

Exclusion criteria: unstable haemodynamic state, administration of morphine, atropine, theophylline, barbiturates, and cisapride, and a past history of GER or hiatal hernia.       

Interventions

PEG (n = 19): pull technique

NGT (n = 20): fine bore 14

Outcomes
  1. Investigate if long-standing presence of NGT for feeding is associated with increased incidence of gastro-oesophageal reflux (GER)

  2. Investigate if PEG combined with semi-recumbent position and avoidance of gastric nutrient retention lead to decreased incidence of GER in mechanically-ventilated patients

  3. Mortality

  4. Pneumonia

  5. Adverse events

Notes

Follow-up: 20 days

Three patients randomly allocated to receive PEG were excluded because of hiatal hernia (2) and intestinal bloating

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot explicitly stated by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Low riskFlow of patients was clearly reported
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed
Other biasLow riskNone suspected

Elbadawy 2014

Methods

Single-centre parallel randomised controlled 3-arm trial

Setting: Department of Critical Care Medicine, Egypt

Sample size; minimum sample size required was 20 patients for each group to achieve a power of 80 % and alpha of 0.05.

Participants

60 participants, with closed traumatic severe brain injury in need for prolonged MV who continued to have a Glasgow coma score (GCS) of less than 8 after initial stabiliSation of their haemodynamic and oxygenation.

Mean age not available.

Gender (male/female ratio):

NGT + intubation: 8/12

PEG + intubation: 9/11

PEG + tracheostomy: 11/9

Exclusion criteria:

History of known respiratory disease, thoracic trauma, multiple traumatic injuries including abdominal or spinal trauma, massive or untreatable loculated ascites, previous abdominal surgery, uncorrected coagulopathy.

Interventions

NGT + intubation (n = 20): nasogastric tube and endotracheal tube was inserted through which MV was applied.

PEG + intubation (n = 20): PEG was done within 24 hours of endotracheal intubation using percutaneous pull gastrostomy kit using Bard Ponsky pull through technique

PEG + tracheostomy (n = 20): percutaneous dilatational tracheostomy (PDT) and PEG were done within 24 hours of endotracheal intubation.

In all study groups, bolus enteral nutrition was given which was initiated within 24 hours after intubation for patients in group (A) and 24 hours after performance of gastrostomy for group (B and C). All the patients were nursed in a semi recumbent position (30-45o). Proton pump inhibitor was given intravenously for stress ulcer prophylaxis (pantoprazole 40mg once daily) for each patient in all the study groups

Outcomes

Primary

  1. Intervention failures as defined by any event leading to failure to introduce the tube, recurrent displacement and treatment interruption (feeding interruption, blocking or leakage of the tube, no adherence to treatment).

Secondary

  1. Adverse events including ventilation assisted pneumonia

  2. Duration of ICU stay.

  3. Duration of mechanical ventilation

  4. Duration of hospital stay.

  5. Mortality rate of the patients

  6. Vital signs

Adverse events including: infection of tracheostomy wound, bleeding from tracheostomy, pneumothorax, tracheo-oesophageal fistula, infection of gastrostomy wound, GIT Fistula, GIT Perforation, buried pumper syndrome (PEG tube erodes and migrates through the gastric wall), paranasal sinusitis.

Notes

No statistically or clinically significant differences between comparison groups at baseline for gender, mechanism of injury, characteristics based on computer tomography, APACHE II score, Glasgow coma score, or other vital sign sand biochemical parameters.

We combined data for the PEG + intubation and PEG + tracheostomy groups into a single PEG group for comparison with NGT.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskDescribed as randomised, consecutive computer randomisation (further information from study investigator)
Allocation concealment (selection bias)High riskNot concealed (further information from study investigator)
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot explicitly stated by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo attrition reported
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed, protocol not available for assessment
Other biasLow riskNone

Hamidon 2006

Methods

Single-centre parallel randomised controlled trial

Setting: 1 hospital in Malaysia; patients were discharged in one or two days after the intervention

Sample size: not reported

Participants

23 patients; 11 male, 11 female; median age: PEG 65 (48 to 79), NGT 72 (54 to 77)

Inclusion criteria: patients with acute Ischaemic stroke and persistent dysphagia for seven or more days

Exclusion criteria: not related

Interventions

PEG (n = 10): pull technique, Wilson CooK silicone tube 24 FR, inserted by a doctor

NGT (n = 12): Steril Cathline polyurethane tube, size 14 inserted by a nurse and checked by aspirating asteric contents

Outcomes
  1. Nutritional status assessed by recording anthropometric parameters and nutritional markers

  2. Treatment failure

NotesThere was one dropout because it was impossible to contact the patient after four weeks
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random table
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention; although only surgeons were responsible for the PEG and nurses by the NGT
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInformation given by the patients by telephone, but blinding of outcome assessment was not explicitly stated by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Low riskFlow of patients was clearly reported (1 dropout due to failure to turn-up)
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed
Other biasLow riskNone suspected

Norton 1996

Methods

Parallel randomised controlled trial

Setting: 1 university hospital and one district general hospital in UK

Sample size: not reported

Participants

30 patients: 11 male, 19 female; mean age 77

Inclusion criteria: acute cerebrovascular accident with persisting dysphagia for eight or more days, in need for sedation and prolonged mechanical ventilation.

Exclusion criteria: patients with a previous history of gastrointestinal disease which would preclude siting a gastrostomy tube or who were unfit for upper gastrointestinal endoscopy and IV sedation

Interventions

PEG (n = 16): pull technique, Wilson Cook tube 24 FR or 12 FR Fresenius

NGT (n = 14): fine bore tube Flocare 500, inserted by a senior nurse

Outcomes
  1. Mortality

  2. Treatment failure

  3. Adverse events

  4. Pneumonia

  5. Amount of feed administered

  6. Change in nutritional status

  7. Length of hospital stay

Notes

Follow-up: six weeks for main outcomes

For continuous data, results were not available for all patients

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Low riskSealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot explicitly stated by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Low riskFlow of patients was clearly reported
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed
Other biasLow riskNone suspected

Park 1992

Methods

Parallel randomised controlled trial

Setting: three teaching hospitals in Glasgow

Sample size: 40 patients was selected to detect a two-sided difference between the success of gastrostomy feeding at 90% and NGT feeding at 40% with a power of 0.9 and significance of 0.05

Participants

40 patients with neurological dysphagia, 22 male, 18 female; mean age: PEG 56, NGT 65

Inclusion criteria: longstanding (4 weeks or more) dysphagia due to neurological disease; stable medical condition with likely survival of at least one month; ability to communicate verbally or in writing; and presence of a normal gastrointestinal tract

Exclusion criteria: dementia; mechanical lesions causing obstruction of the oesophagus or stomach; active intra-abdominal inflammation including inflammatory bowel disease or pancreatitis; history of partial gastrectomy, reflux oesophagitis, or intestinal obstruction; and presence of ascites, notable hepatomegaly, severe obesity, coagulopathy, untreated aspiration pneumonia, and major systemic disease including malignancy and respiratory, liver, or renal failure

Interventions

PEG (n = 20) Bard 20Fr silicone tube, technique by Ponsky - Gauderer

NGT (n = 20) fine bore Abbott Flexitube, polyurethane, 850 mm length,1.5 mm internal diameter

Outcomes
  1. Mortality

  2. Duration of feeding (days)

  3. Treatment failure

  4. Adverse events

  5. Pneumonia

  6. Nutritional status (weight, albumin, mean difference weight, mid-arm muscle circumference, triceps skin fold thickness)

  7. Received/prescribed feed

Notes

Outcome six was not considered for analysis because only one patient completed the follow-up

Outcome seven was not considered clinically relevant by itself, unless it causes failure or affects nutritional status (anthropometric parameters)

Follow-up: 28 days

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskComputer-generated random numbers (Epistat Statistical Package)
Allocation concealment (selection bias)Low riskSealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot explicitly stated by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Low riskFlow of patients was clearly reported
Selective reporting (reporting bias)Low riskRelevant outcomes were analysed
Other biasHigh riskThere was 95% (19/20) of dropouts in the NGT group due to failures in the treatment and death

Sadasivan 2012

Methods

Single-centre parallel randomised controlled trial.

Sample size: a minimum of 40 cases in each group, with 80%- to –90% power and 95% confidence (80% on tube dislodgement and 90% on infection). So, 50 cases were included in each group.

Setting: India, Department of ENT (Ear, Nose, Throat; Otorhinolaryngology).

Participants

100 participants

Gender: PEG: 34/16 (male/female ratio); NGT: 33/17 (male/female ratio)

Age (mean): not reported

Inclusion criteria: patients with advanced stage 2 or 3 squamous cell carcinoma of the head and neck and who were scheduled either for radical surgery with adjuvant radiotherapy (RT), chemo-RT, or for concurrent chemo and radiation therapy were included in the study.

Exclusion criteria: patients with early stage 1 or 2 head and neck cancer were excluded from the study

Interventions

PEG n = 50; NGT n = 50

The majority of NG tubes were inserted by nurses, all PEG tubes were inserted by gastroenterologists.

Outcomes

Follow-up: 1 week; 6 weeks and 6 month

Primary outcomes

  1. Intervention failures as defined by any event leading to failure to introduce the tube, recurrent displacement and treatment interruption (feeding interruption, blocking or leakage of the tube, no adherence to treatment) (based on Norton 1996).

Secondary outcomes

  1. Nutritional status, as measured by any validated instrument (such as upper-arm skin fold thickness, mid-arm circumference, body weight, serum albumin level, haemoglobin (Ramel 2008)).

  2. Quality of life, EORTC QLQH& N35 at 6 weeks (Dorman 1997)): pain, learning to use, inconvenience, uncomfortable feeds, altered body image, family life, social activities.

NotesStatistical differences at baseline: radical surgery and adjuvant radiotherapy or chemo and radiation therapy (PEG: 92%; NGT: 72%; P = 0.01); concurrent chemo- and radiation therapy (PEG: 8%; NGT: 28% P = 0.01); baseline weight: PEG: 56.5 versus NGT: 61 (P < 0.01)
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported by the study investigators
Allocation concealment (selection bias)Unclear riskNot reported by the study investigators
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot reported by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskStudy investigators did not perform ITT analysis
Selective reporting (reporting bias)Low riskNone suspected: relevant variables were analysed. The protocol was not assessed.
Other biasUnclear riskNone suspected

Yata 2001

  1. a

    GER: gastroesophogeal reflux
    ITT: intention-to-treat
    IV: intravenous
    NGT: nasogastric tube
    PEG: percutaneous endoscopic gastrostomy
    QoL: quality of life

Methods

Single-centre parallel randomised controlled trial.

Sample size: not reported

Setting: 1 hospital in Inagawa Town (Japan)

Participants

82 patients: 22 male, 60 female; mean age: PEG 75.1 (50 to 96), NGT 76.5 (38 to 93)

Inclusion criteria: dysphagic patients

Exclusion criteria: not reported

Interventions

PEG n = 42

NGT n = 40

Outcomes
  1. Nutrition status (albumin, haemoglobin and cholesterol)

  2. Adverse events

  3. Mean survival time

  4. Pneumonia

  5. Reflux oesophagitis

  6. Anaemia

  7. Peristomal leakage

  8. Gastric ulcer

  9. Treatment failure

NotesStudy available only as a meeting abstract
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot reported
Allocation concealment (selection bias)Unclear riskNot reported
Blinding of participants and personnel (performance bias)
All outcomes
High riskNot possible for this type of intervention
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot explicitly described by the study investigators
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskFlow of patients was not clearly reported
Selective reporting (reporting bias)Low risk

Relevant outcomes were analysed,

Outcome 7. was reported only for NGT group

Outcomes 8 and 9 were reported only for the PEG group

Other biasHigh riskUnpublished study

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
McClave 2005Retrospective study
Mekhail 2001Randomised controlled trial with intervention out of interest for this review (patients randomised to stop the enteral nutrition according to different residual gastric volume)
Schulz 2009Retrospective study

Ancillary