应用纤维蛋白密封剂预防胰腺手术后胰瘘
Información
- DOI:
- https://doi.org/10.1002/14651858.CD009621.pub3Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 23 junio 2018see 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 © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
Conceiving the review: YC.
Designing the review: Junhua Gong.
Co‐ordinating the review: SH.
Designing search strategies: YC.
Study selection: Junhua Gong, YC
Data extraction: NC, Jianping Gong.
Writing the review: Junhua Gong, SH.
Providing general advice on the review: ZZ.
Securing funding for the review: Jianping Gong.
Performing previous work that was the foundation of the current study: YC.
Sources of support
Internal sources
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Kunming Medical University, China.
Provided funding for the review.
External sources
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No sources of support supplied
Declarations of interest
Junhua Gong: none known.
SH: none known.
YC: none known.
NC: none known.
Jianping Gong: none known.
ZZ: none known.
Acknowledgements
We acknowledge the contribution of authors of previous version of this review: Cheng Y, Ye M, Xiong X, Peng S, Wu HM, Cheng N, Gong J.
We acknowledge the help and support of the Cochrane Upper Gastrointestinal and Pancreatic Diseases Review Group. The authors would also like to thank the following editors and peer referees who provided comments to improve the review: Sarah Rhodes (Editor), and Paul Moayyedi (Editor), and to Jessica Sharp for copy‐editing the review.
The methods section of this review is based on a standard template used by Cochrane Upper Gastrointestinal and Pancreatic Diseases Review Group.
Version history
| Published | Title | Stage | Authors | Version |
| 2023 Jun 19 | Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery | Review | Mingliang Lai, Shiyi Zhou, Sirong He, Yao Cheng, Nansheng Cheng, Yilei Deng, Xiong Ding | |
| 2020 Mar 11 | Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery | Review | Yilei Deng, Sirong He, Yao Cheng, Nansheng Cheng, Jianping Gong, Junhua Gong, Zhong Zeng, Longshuan Zhao | |
| 2018 Jun 23 | Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery | Review | Junhua Gong, Sirong He, Yao Cheng, Nansheng Cheng, Jianping Gong, Zhong Zeng | |
| 2016 Feb 15 | Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery | Review | Yao Cheng, Mingxin Ye, Xianze Xiong, Su Peng, Hong Mei Wu, Nansheng Cheng, Jianping Gong | |
| 2012 Feb 15 | Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery | Protocol | Yao Cheng, Xianze Xiong, Su Peng, Hong Mei Wu, Nansheng Cheng | |
Differences between protocol and review
For rare events, the Peto method has been observed to be less biased and more powerful than other methods. Thus we calculated the Peto odds ratio instead of risk ratio for rare events (mortality).
Differences between 2016 review and 2018 update
In the 2016 review, we included nine randomised controlled trials but the patient cohort was very heterogenous, including those undergoing a pancreaticoduodenectomy (Whipple's procedure) and those undergoing a distal pancreatectomy. Therefore some participants had an anastomosis and some had a transection with closure of the stump of pancreas. There were also other obvious variables such as different sealing methods and different types of fibrin sealants, which were so dissimilar that they should not be combined in the same meta‐analysis. In the 2018 update, we did not perform a meta‐analysis of fibrin sealants versus no fibrin sealants for overall pancreatic surgery. Instead, we split all of the studies into three subgroups according to different operations and different sealing methods and performed subgroup analysis of different types of fibrin sealants.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Fibrin Tissue Adhesive [adverse effects, *therapeutic use];
- Length of Stay;
- Pancreas [*surgery];
- Pancreatectomy [methods];
- Pancreatic Fistula [*prevention & control];
- Postoperative Complications [mortality, *prevention & control];
- Randomized Controlled Trials as Topic;
- Reoperation [statistics & numerical data];
- Tissue Adhesives [*therapeutic use];
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.
Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 1 Postoperative pancreatic fistula (ISGPF definition).
Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 2 Postoperative mortality.
Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 3 Overall postoperative morbidity.
Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 4 Reoperation rate.
Comparison 1 Fibrin sealants versus no fibrin sealant (pancreatic stump closure reinforcement after distal pancreatectomy), Outcome 5 Length of hospital stay.
Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 1 Postoperative pancreatic fistula (ISGPF definition).
Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 2 Postoperative mortality.
Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 3 Overall postoperative morbidity.
Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 4 Reoperation rate.
Comparison 2 Fibrin sealants versus no fibrin sealant (pancreatic anastomosis reinforcement after pancreaticoduodenectomy), Outcome 5 Length of hospital stay.
Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 1 Postoperative mortality.
Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 2 Overall postoperative morbidity.
Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 3 Reoperation rate.
Comparison 3 Fibrin sealants versus no fibrin sealant (pancreatic duct occlusion after pancreaticoduodenectomy), Outcome 4 Length of hospital stay.
| Application of fibrin sealants to pancreatic stump closure reinforcement for the prevention of postoperative pancreatic fistula following distal pancreatectomy | ||||||
| Patient or population: people undergoing distal pancreatectomy Setting: hospital Intervention: fibrin sealant | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
| Risk with no fibrin sealants | Risk with fibrin sealants | |||||
| Postoperative pancreatic fistula (ISGPF definition) Follow up: 30 days | Study population | RR 0.96 | 755 | ⊕⊕⊝⊝ | ||
| 201 per 1000 | 193 per 1000 | |||||
| Moderate | ||||||
| 203 per 1000 | 195 per 1000 | |||||
| Postoperative mortality | Study population | Peto OR 0.52 | 804 | ⊕⊕⊝⊝ | ||
| 5 per 1000 | 3 per 1000 | |||||
| Moderate | ||||||
| 0 per 1000 | 0 per 1000 | |||||
| Overall postoperative morbidity Follow up: 30 days | Study population | RR 1.23 | 646 | ⊕⊕⊝⊝ | ||
| 232 per 1000 | 285 per 1000 | |||||
| Moderate | ||||||
| 239 per 1000 | 294 per 1000 | |||||
| Reoperation rate Follow up: 30 days | Study population | RR 0.51 | 376 | ⊕⊝⊝⊝ | ||
| 38 per 1000 | 20 per 1000 | |||||
| Moderate | ||||||
| 27 per 1000 | 14 per 1000 | |||||
| Serious adverse events | This outcome was not reported in any of the included studies. | |||||
| Quality of life | This outcome was not reported in any of the included studies. | |||||
| Cost effectiveness | This outcome was not reported in any of the included studies. | |||||
| Length of hospital stay (days) | The mean length of hospital stay was 11.4 days | The mean length of hospital stay was 0.32 days higher (1.06 lower to 1.70 higher) | MD 0.32 (‐1.06 to 1.70) | 755 | ⊕⊕⊕⊝ | |
| *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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded one level for serious risk of bias. | ||||||
| Application of fibrin sealants to pancreatic anastomosis reinforcement for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy | ||||||
| Patient or population: people undergoing pancreaticoduodenectomy Intervention: fibrin sealant Comparison: no fibrin sealant | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
| Risk with no fibrin sealants | Risk with fibrin sealants | |||||
| Postoperative pancreatic fistula (ISGPF definition) Follow up: 30 days | Study population | RR 0.25 | 57 | ⊕⊝⊝⊝ | ||
| 62 per 1000 | 16 per 1000 | |||||
| Moderate | ||||||
| 63 per 1000 | 16 per 1000 | |||||
| Postoperative mortality Follow up: 30 days | Study population | Peto OR 0.15 | 251 | ⊕⊕⊝⊝ | ||
| 7 per 1000 | 1 per 1000 | |||||
| Moderate | ||||||
| 0 per 1000 | 0 per 1000 | |||||
| Overall postoperative morbidity Follow up: 30 days | Study population | RR 0.97 | 181 | ⊕⊝⊝⊝ | ||
| 347 per 1000 | 337 per 1000 | |||||
| Moderate | ||||||
| 370 per 1000 | 359 per 1000 | |||||
| Reoperation rate Follow up: 30 days | Study population | RR 0.83 | 181 | ⊕⊝⊝⊝ | ||
| 92 per 1000 | 76 per 1000 | |||||
| Moderate | ||||||
| 133 per 1000 | 110 per 1000 | |||||
| Serious adverse events | This outcome was not reported in any of the included studies. | |||||
| Quality of life | This outcome was not reported in any of the included studies. | |||||
| Cost effectiveness | This outcome was not reported in any of the included studies. | |||||
| Length of hospital stay (days) | The mean length of hospital stay was 14.8 days | The mean length of hospital stay was 1.58 days lower | MD −1.58 | 181 | ⊕⊕⊝⊝ | |
| *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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded one level for serious risk of bias. | ||||||
| Application of fibrin sealants to pancreatic duct occlusion for the prevention of postoperative pancreatic fistula following pancreaticoduodenectomy | ||||||
| Patient or population: people undergoing pancreaticoduodenectomy Intervention: fibrin sealant Comparison: no fibrin sealant | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No of participants | Quality of the evidence | Comments | |
| Risk with no fibrin sealants | Risk with fibrin sealants | |||||
| Postoperative pancreatic fistula (ISGPF definition) | This outcome was not reported in any of the included studies. | |||||
| Postoperative mortality Follow up: 30 days | Study population | Peto OR 1.41 | 351 | ⊕⊕⊝⊝ | ||
| 61 per 1000 | 84 per 1000 | |||||
| Moderate | ||||||
| 61 per 1000 | 84 per 1000 | |||||
| Overall postoperative morbidity Follow up: 30 days | Study population | RR 1.16 | 351 | ⊕⊝⊝⊝ | ||
| 276 per 1000 | 320 per 1000 | |||||
| Moderate | ||||||
| 277 per 1000 | 321 per 1000 | |||||
| Reoperation rate Follow up: 30 days | Study population | RR 0.85 | 351 | ⊕⊝⊝⊝ | ||
| 160 per 1000 | 136 per 1000 | |||||
| Moderate | ||||||
| 160 per 1000 | 136 per 1000 | |||||
| Serious adverse events (Diabetes mellitus) Follow‐up: 3 to 12 months | 3 months follow up | ‐ | 169 (1 study) | ⊕⊕⊝⊝ | ||
| 108 per 1000 | 337 per 1000 | |||||
| 12 months follow up | ||||||
| 145 per 1000 | 337 per 1000 | |||||
| Quality of life | This outcome was not reported in any of the included studies. | |||||
| Cost effectiveness | This outcome was not reported in any of the included studies. | |||||
| Length of hospital stay (days) | The mean length of hospital stay was 16.5 days | The mean length of hospital stay was 0.58 days higher (5.74 lower to 6.89 higher) | MD 0.58 (‐5.74 to 6.89) | 351 (2 studies) | ⊕⊕⊝⊝ | |
| *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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Downgraded two levels for very serious imprecision (small sample size, confidence intervals of risk ratios overlapped 0.75 and 1.25). | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Postoperative pancreatic fistula (ISGPF definition) Show forest plot | 4 | 755 | Risk Ratio (M‐H, Random, 95% CI) | 0.96 [0.68, 1.35] |
| 1.1 Fibrin glue | 1 | 109 | Risk Ratio (M‐H, Random, 95% CI) | 1.02 [0.44, 2.37] |
| 1.2 Fibrin sealant patch | 3 | 646 | Risk Ratio (M‐H, Random, 95% CI) | 0.91 [0.58, 1.45] |
| 2 Postoperative mortality Show forest plot | 6 | 804 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.52 [0.05, 5.03] |
| 2.1 Fibrin glue | 3 | 158 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.0 [0.0, 0.0] |
| 2.2 Fibrin sealant patch | 3 | 646 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.52 [0.05, 5.03] |
| 3 Overall postoperative morbidity Show forest plot | 3 | 646 | Risk Ratio (M‐H, Random, 95% CI) | 1.23 [0.97, 1.58] |
| 4 Reoperation rate Show forest plot | 2 | 376 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.15, 1.71] |
| 5 Length of hospital stay Show forest plot | 4 | 755 | Mean Difference (IV, Random, 95% CI) | 0.32 [‐1.06, 1.70] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Postoperative pancreatic fistula (ISGPF definition) Show forest plot | 1 | 57 | Risk Ratio (M‐H, Random, 95% CI) | 0.25 [0.01, 5.06] |
| 1.1 Fibrin glue | 1 | 57 | Risk Ratio (M‐H, Random, 95% CI) | 0.25 [0.01, 5.06] |
| 1.2 Fibrin sealant patch | 0 | 0 | Risk Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] |
| 2 Postoperative mortality Show forest plot | 3 | 251 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.15 [0.00, 7.76] |
| 2.1 Fibrin glue | 3 | 251 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.15 [0.00, 7.76] |
| 2.2 Fibrin sealant patch | 0 | 0 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.0 [0.0, 0.0] |
| 3 Overall postoperative morbidity Show forest plot | 2 | 181 | Risk Ratio (M‐H, Random, 95% CI) | 0.97 [0.65, 1.45] |
| 4 Reoperation rate Show forest plot | 2 | 181 | Risk Ratio (M‐H, Random, 95% CI) | 0.83 [0.33, 2.11] |
| 5 Length of hospital stay Show forest plot | 2 | 181 | Mean Difference (IV, Random, 95% CI) | ‐1.58 [‐3.96, 0.81] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Postoperative mortality Show forest plot | 2 | 351 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 1.41 [0.63, 3.13] |
| 1.1 Fibrin glue | 2 | 351 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 1.41 [0.63, 3.13] |
| 1.2 Fibring sealant patch | 0 | 0 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.0 [0.0, 0.0] |
| 2 Overall postoperative morbidity Show forest plot | 2 | 351 | Risk Ratio (M‐H, Random, 95% CI) | 1.16 [0.67, 2.02] |
| 3 Reoperation rate Show forest plot | 2 | 351 | Risk Ratio (M‐H, Random, 95% CI) | 0.85 [0.52, 1.41] |
| 4 Length of hospital stay Show forest plot | 2 | 351 | Mean Difference (IV, Random, 95% CI) | 0.58 [‐5.74, 6.89] |
