مقایسه بازسازی به روش Roux‐en‐Y در برابر Billroth‐I پس از انجام گاسترکتومی دیستال برای سرطان معده
Información
- DOI:
- https://doi.org/10.1002/14651858.CD012998.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 15 septiembre 2021see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Salud digestiva
- Copyright:
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- Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Autores
Contributions of authors
All review authors contributed to the production of the protocol.
DN and RG identified studies for inclusion and checked the methodological quality of studies.
DN and RG extracted data and assessed risk of bias of the studies.
DN performed the analyses.
KO and DN contacted trial authors and manufacturers.
DN and NH performed the GRADE assessment.
NH, KH, KO, TAF, and YS provided general advice on the review.
NW supervised the conducting of the review.
DN wrote the final review, which was approved by the other authors.
Sources of support
Internal sources
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No sources of support provided
External sources
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No sources of support provided
Declarations of interest
DN: none known.
RG: none known.
NH has received writing fees from Igaku‐Shoin and Kanehara publishers.
KH has received grants for research from JSPS KAKENHI, Mitsubishi Foundation, Senko Medical, Kondo Memorial Foundation, and Japan Society of Laparoscopic Colorectal Surgery outside the submitted work. He has received lecture fees from Johnson & Johnson, Medtronic, and Otsuka Pharmaceutical Company outside the submitted work.
KO has received grants or research support from the Japan Agency for Medical Research and Development and the Japan Society for the Promotion of Science (JSPS KAKENHI). He has received grants from Taiho Pharmaceuticals, consultant fee from Ethicon, Stryker, Olympus, Medicaroid, Medtronic, and Intuitive Surgical, and payment for lectures from Ethicon, Covidien Japan, Intuitive Surgical, Taiho Pharmaceuticals, Chugai Pharmaceuticals, Tsumura Pharmaceuticals, Miyarisan Pharmaceuticals, EA Pharma, Otsuka Pharmaceuticals, Kaken Pharmaceuticals, Gunze Medical Japan, Medicon, Ono Pharmaceuticals, and Olympus.
TAF has received lecture fees from Eli Lilly, Janssen, Meiji, Mitsubishi‐Tanabe, MSD, and Pfizer and consultancy fees from Takeda Science Foundation, Mitsubishi‐Tanabe, Shionogi and SONY. He has received royalties from Igaku‐Shoin and Nihon Bunka Kagaku‐sha publishers. He has received research support from Mochida and Mitsubishi‐Tanabe and Shionogi. He has a patent 2020‐548587 concerning smartphone CBT apps pending, and intellectual properties for Kokoro‐app licensed to Mitsubishi‐Tanabe.
YS has received grants from Chugai, Taiho, Tsumura, Daiichi‐Sankyo, Yakult, Otsuka, Shionogi, and Sanofi, and payment for lectures from Chugai, Taiho, Tsumura, Johnson & Johnson, Covidien Japan, Striker Japan, Olympus, Takeda, and Terumo, outside the submitted work.
NW has received research funds from the Japanese Ministry of Health Labor and Welfare and the Japanese Ministry of Education, Science, and Technology. He has also received royalties from Sogensha and advantage Risk Management for writings. The results in the review are completely independent of the intention of these grants.
Affiliations of all members involved in this review have been unchanged for the past three years.
Nobody involved in this review is an investigator of a study that might be included in the review.
Acknowledgements
We acknowledge the help and support of the Cochrane Gut Group. We thank Teo Quay (Managing Editor), Yuhong Yuan (Information Specialist and former Managing Editor), and Karin Dearness (former Managing Editor of Cochrane Upper Gastrointestinal and Pancreatic Diseases (now Cochrane Gut)) for providing administrative and logistical support for the conduct of the review.
The authors would also like to thank the following editors and peer referees, who provided comments to improve the protocol and the review: Grigorios Leontiadis (Co‐ordinating Editor), Sarah Rhodes (Editor), Takeshi Kanno (Editor), Hideaki Shimada (Peer Referee), Kouji Nakada (Peer Referee) and Alfretta Vanderheyden (Consumer Referee). The search strategies were designed and run by Yuhong Yuan (Information Specialist, Cochrane Gut). We thank Lisa Winer for copy‐editing this review.
We appreciate Sang‐Yong Son, Hoon Hur, and Sang‐Uk Han at Ajou University, and Masaki Nakamura at Wakayama Medical University Hospital for kindly providing us with their unpublished data.
The Methods section of this review is based on a standard template used by Cochrane Gut Group.
Version history
| Published | Title | Stage | Authors | Version |
| 2021 Sep 15 | Roux‐en‐Y versus Billroth‐I reconstruction after distal gastrectomy for gastric cancer | Review | Daisuke Nishizaki, Riki Ganeko, Nobuaki Hoshino, Koya Hida, Kazutaka Obama, Toshi A Furukawa, Yoshiharu Sakai, Norio Watanabe | |
| 2018 Apr 03 | Roux‐en‐Y versus Billroth‐I reconstruction after distal gastrectomy for gastric cancer | Protocol | Daisuke Nishizaki, Riki Ganeko, Nobuaki Hoshino, Koya Hida, Kazutaka Obama, Toshi A Furukawa, Yoshiharu Sakai, Norio Watanabe | |
Differences between protocol and review
We changed the inclusion period for the assessment of body weight loss. We initially defined the period of 12 to 24 months after surgery, but changed it from 6 months to 24 months because we focused on the short‐term effect of reconstruction methods which may affect the dose of adjuvant chemotherapy. Also, we set an inclusion period for the assessment of bile reflux since this was not defined in the published protocol.
We included one study that had mixed populations of gastric cancer and benign disease (D'Amato 1999). We did not a priori state how to handle mixed populations in the protocol. However, we considered it appropriate to include this study rather than exclude it, in order to consider all gastric cancer patients. We also performed a sensitivity analysis by excluding this study.
Following the advice from the Cochrane audit, we changed i) the criteria for judgement of heterogeneity from the threshold of I² statistics to the range of I² statistics, and ii) added the rationale for subgroups.
We adopted the formula to calculate the mean and the standard deviation from the median, ranges, and sample size.
In subgroup analyses by surgical approaches, we used three subgroups (open surgery, laparoscopic surgery, and others) in the review, although only two subgroups (open surgery and others) were prespecified in the published protocol.
We only assessed the incidence of bile reflux in the review, not the severity of remnant gastritis, although severity of remnant gastritis was prespecified in the protocol: this was because we considered that alpha‐error would increase as the number of outcomes increased, and it would not be relevant for patients when the grade of the RGB (Residue, Gastritis, Bile) classification was an indicator of efficacy.
Since the incidence of anastomotic leakage was sparse, we decided not to conduct the prespecified subgroup analysis for this outcome.
We prespecified a sensitivity analysis by excluding studies with stage IV patients, but decided not to conduct this analysis because the proportion of stage IV patients included in each study was small.
We performed a sensitivity analysis on length of hospital stay by excluding the study with skewed data to confirm the robustness of the result, although this analysis was not prespecified in the protocol. We also performed a sensitivity analysis on overall morbidity by excluding the studies for which use of the Clavien‐Dindo classification was unknown, which was not prespecified in the protocol. Likewise, we performed post hoc sensitivity analyses as follows:
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using a fixed‐effect model for anastomotic leakage;
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excluding the study that included benign disease patients and the study with co‐intervention bias for health‐related quality of life; and
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excluding the study that included only diabetic patients for body weight loss.
We did not note the criteria for defining disease stage in the published protocol; thus, we stated that we would use the 15th edition of the Japanese Classification of Gastric Carcinoma.
We noted who assessed the certainty of evidence in the review, as this information was not provided in the protocol.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Humans;
PICO
Study flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.1 Health‐related quality of life.
Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.2 Incidence of anastomotic leakage.
Forest plot of comparison: 1 Roux‐en‐Y versus Billroth‐I reconstruction, outcome: 1.3 Loss of body weight.
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Health‐related quality of life
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Incidence of anastomotic leakage
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Loss of body weight
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Incidence of bile reflux
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 5: Length of hospital stay
Comparison 1: Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 6: Postoperative morbidity
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Health‐related quality of life based on surgical approach
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Loss of body weight based on surgical approach
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Health‐related quality of life based on cancer stage
Comparison 2: Subgroup analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Loss of body weight based on cancer stage
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 1: Length of hospital stay in studies without skewed data
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 2: Postoperative morbidity in studies in which use of Clavien‐Dindo classification was not unclear
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 3: Incidence of anastomotic leakage with a fixed‐effect model
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 4: Health‐related quality of life in studies without benign disease patients
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 5: Loss of body weight in studies not limited to diabetic patients
Comparison 3: Sensitivity analysis in Roux‐en‐Y versus Billroth‐I reconstruction, Outcome 6: Health‐related quality of life in studies without co‐intervention bias
| Roux‐en‐Y compared to Billroth‐I after distal gastrectomy for gastric cancer | ||||||
| Patient or population: people undergoing distal gastrectomy for gastric cancer | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with Billroth‐I | Risk with Roux‐en‐Y | |||||
| Health‐related quality of life | ‐ | SMD 0.04 higher | ‐ | 695 | ⊕⊕⊝⊝ | Regarding the effect size of the SMD, 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988). Converting an SMD of 0.04 into a global health status score of EORTC QLQ‐C30, Roux‐en‐Y may increase it by 0.56 points (95% CI −1.53 to 2.50) (Murad 2019). |
| Incidence of anastomotic leakage | 14 per 1000 | 9 per 1000 | RR 0.63 | 711 | ⊕⊝⊝⊝ | |
| Loss of body weight | The mean loss of body weight ranged from 8 to 9 percent. | The mean loss of body weight was 0.41% greater | ‐ | 541 | ⊕⊕⊝⊝ | Loss of body weight is expressed as a percentage (e.g. if a person of 50 kg becomes 40 kg, the loss of body weight is 20%). Weight loss can theoretically range from negative infinity to 100%, but weight gain is uncommon after gastrectomy, and weight loss of more than 50% is also uncommon. The observed values are therefore usually expected to fall within the range of 0 to 50%. |
| Incidence of bile reflux | 397 per 1000 | 159 per 1000 | RR 0.40 | 399 | ⊕⊕⊕⊝ | |
| Length of hospital stay | The mean length of hospital stay ranged from 7 to 23 days. | The mean length of hospital stay was 0.96 days longer | ‐ | 894 | ⊕⊝⊝⊝ | Length of hospital stay is expressed in days, and ranges from 1 to infinite. |
| Postoperative morbidity | 99 per 1000 | 146 per 1000 | RR 1.47 | 891 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (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; EORTC QLQ‐C30: EORTC Core Quality of Life Questionnaire ‐ Core Questionnaire; RCT: randomised controlled trial; RR: risk ratio; SMD: standardised mean difference | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1Downgraded one level due to imprecision; 95% CIs are compatible with both benefit and harm. | ||||||
| Study | Roux‐en‐Y | Affected participants in Roux‐en‐Y | Billroth‐I | Affected participants in Billroth‐I |
|---|---|---|---|---|
| 1 Atelectasis 1 Bleeding | 2/20 | 1 Atelectasis 1 Complicated fluid | 2/20 | |
| 3 Postoperative ileus 1 Pneumonia 1 Leakage 1 Wound seroma 1 Voiding difficulty | 6/58 | 1 Postoperative ileus 1 Pneumonia 1 Intra‐abdominal fluid 1 Cholecystitis 1 Voiding difficulty 2 Unknown fever | 7/56 | |
| 10 Pulmonary complications 1 Acute cholecystitis 2 Superficial surgical site infection 2 Intra‐abdominal infection 1 Adhesive ileus 1 Acute urinary retention 1 Gastroplegia | 14/70 | 10 Pulmonary complications 1 Acute cholecystitis 1 Acute urinary retention 1 Gastroplegia | 11/70 | |
| 4 Delayed gastric emptying 1 Pancreatic fistula 2 Anastomotic stricture 1 Pancreatic fistula 1 Postoperative bleeding | 9/59 | 1 Surgical site infection 2 Anastomotic leakage 1 Anastomotic stricture | 4/60 | |
| 1 Anastomotic leakage 2 Gastorojejunostomy outlet obstruction 2 Intra‐abdominal abscess 1 Deep vein thrombosis | 6/47 | 2 Bleeding 1 Wound problem 1 Chyle leakage | 4/49 | |
| 3 Pancreatic fistula 3 Abdominal abscess 2 Bowel obstruction 2 Postoperative pancreatitis 2 Surgical site infection 2 Anastomotic stricture | 23/169 | 2 Pancreatic fistula 2 Anastomotic leakage 3 Abdominal abscess 1 Bowel obstruction 2 Postoperative pancreatitis 3 Surgical site infection 3 Anastomotic stricture | 14/163 | |
| 3 Gastric stasis 1 Intestinal obstruction 1 Pneumonia 2 Anastomotic stricture | 6/24 | 1 Leakage 1 Intestinal obstruction | 2/26 |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Health‐related quality of life Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 1.2 Incidence of anastomotic leakage Show forest plot | 5 | 711 | Risk Ratio (M‐H, Random, 95% CI) | 0.63 [0.16, 2.53] |
| 1.3 Loss of body weight Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| 1.4 Incidence of bile reflux Show forest plot | 4 | 399 | Risk Ratio (M‐H, Random, 95% CI) | 0.40 [0.25, 0.63] |
| 1.5 Length of hospital stay Show forest plot | 7 | 894 | Mean Difference (IV, Random, 95% CI) | 0.96 [0.16, 1.76] |
| 1.6 Postoperative morbidity Show forest plot | 7 | 891 | Risk Ratio (M‐H, Random, 95% CI) | 1.47 [1.02, 2.11] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Health‐related quality of life based on surgical approach Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 2.1.1 Open studies | 2 | 404 | Std. Mean Difference (IV, Random, 95% CI) | 0.15 [‐0.05, 0.34] |
| 2.1.2 Laparoscopic studies | 1 | 106 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.21 [‐0.59, 0.17] |
| 2.1.3 Mixed and unknown studies | 3 | 185 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.07 [‐0.35, 0.22] |
| 2.2 Loss of body weight based on surgical approach Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| 2.2.1 Open studies | 1 | 332 | Mean Difference (IV, Random, 95% CI) | 0.60 [‐0.87, 2.07] |
| 2.2.2 Laparoscopic studies | 1 | 40 | Mean Difference (IV, Random, 95% CI) | ‐0.70 [‐4.48, 3.08] |
| 2.2.3 Mixed and unknown studies | 2 | 169 | Mean Difference (IV, Random, 95% CI) | 0.34 [‐2.01, 2.68] |
| 2.3 Health‐related quality of life based on cancer stage Show forest plot | 6 | 695 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 2.3.1 Early stage studies | 3 | 490 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.02 [‐0.20, 0.17] |
| 2.3.2 Mixed and unknown studies | 3 | 205 | Std. Mean Difference (IV, Random, 95% CI) | 0.15 [‐0.13, 0.42] |
| 2.4 Loss of body weight based on cancer stage Show forest plot | 4 | 541 | Mean Difference (IV, Random, 95% CI) | 0.41 [‐0.77, 1.59] |
| 2.4.1 Early stage studies | 3 | 491 | Mean Difference (IV, Random, 95% CI) | 0.37 [‐0.86, 1.59] |
| 2.4.2 Mixed and unknown studies | 1 | 50 | Mean Difference (IV, Random, 95% CI) | 0.90 [‐3.43, 5.23] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Length of hospital stay in studies without skewed data Show forest plot | 5 | 722 | Mean Difference (IV, Random, 95% CI) | 0.62 [0.16, 1.09] |
| 3.2 Postoperative morbidity in studies in which use of Clavien‐Dindo classification was not unclear Show forest plot | 5 | 463 | Risk Ratio (M‐H, Random, 95% CI) | 1.39 [0.87, 2.24] |
| 3.3 Incidence of anastomotic leakage with a fixed‐effect model Show forest plot | 5 | 711 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.61 [0.19, 1.93] |
| 3.4 Health‐related quality of life in studies without benign disease patients Show forest plot | 5 | 665 | Std. Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.12, 0.19] |
| 3.5 Loss of body weight in studies not limited to diabetic patients Show forest plot | 3 | 501 | Mean Difference (IV, Random, 95% CI) | 0.53 [‐0.72, 1.77] |
| 3.6 Health‐related quality of life in studies without co‐intervention bias Show forest plot | 5 | 559 | Std. Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.18, 0.15] |
