Fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery
Abstract
Background
Postoperative pancreatic fistula is one of the most frequent and potentially life‐threatening complications following pancreatic resections. Fibrin sealants are introduced to reduce postoperative pancreatic fistula by some surgeons. However, the use of fibrin sealants during pancreatic surgery is controversial.
Objectives
To assess the safety, effectiveness, and potential adverse effects of fibrin sealants for the prevention of postoperative pancreatic fistula following pancreatic surgery.
Search methods
We searched The Cochrane Library (2015, Issue 7), MEDLINE (1946 to 26 August 2015), EMBASE (1980 to 26 August 2015), Science Citation Index Expanded (1900 to 26 August 2015), and Chinese Biomedical Literature Database (CBM) (1978 to 26 August 2015).
Selection criteria
We included all randomized controlled trials that compared fibrin sealant group (fibrin glue or fibrin sealant patch) versus control group (no fibrin sealant or placebo) in people undergoing pancreatic surgery.
Data collection and analysis
Two review authors independently identified the trials for inclusion, collected the data, and assessed the risk of bias. We performed the meta‐analyses using Review Manager 5. We calculated the risk ratio (RR) for dichotomous outcomes (or a Peto odds ratio for very rare outcomes), and the mean difference (MD) for continuous outcomes with 95% confidence intervals (CI).
Main results
We included nine trials involving 1095 participants who were randomized to the fibrin sealant group (N = 550) and the control group (N = 545) after pancreatic surgery. All of the trials were at high risk of bias. There was no evidence of differences in overall postoperative pancreatic fistula (fibrin sealant 29.6%; control 31.0%; RR 0.93, 95% CI 0.71 to 1.21; P = 0.58; nine studies; low‐quality evidence), postoperative mortality (3.1% versus 2.1%; Peto OR 1.29, 95% CI 0.59 to 2.82; P = 0.53; eight studies; very low‐quality evidence), overall postoperative morbidity (29.6% versus 28.9%; RR 1.04, 95% CI 0.82 to 1.32; P = 0.77; five studies), reoperation rate (8.7% versus 10.7%; RR 0.80, 95% CI 0.53 to 1.21; P = 0.29; five studies), or length of hospital stay (12.9 days versus 13.1 days; MD −0.73 days, 95% CI −2.20 to 0.74; P = 0.331; six studies) between the groups. The proportion of postoperative pancreatic fistula that was clinically significant was not mentioned in most trials. On inclusion of trials that clearly distinguished clinically significant fistulas, there was inadequate evidence to establish the effect of fibrin sealants on clinically significant postoperative pancreatic fistula (9.4% versus 13.4%; RR 0.72, 95% CI 0.42 to 1.21; P = 0.21; three studies). Quality of life and cost effectiveness were not reported in any of the trials.
Authors' conclusions
Based on the current available evidence, fibrin sealants do not seem to prevent postoperative pancreatic fistula in people undergoing pancreatic surgery.
PICOs
Plain language summary
Surgical tissue adhesives for the prevention of postoperative pancreatic fistula following pancreatic surgery
Review question
Is surgical tissue adhesive able to reduce postoperative pancreatic fistula after pancreatic surgery?
Background
Postoperative pancreatic fistula is a complication that may follow major surgery for cancer or inflammation of the pancreas, a digestive gland situated at the back of the upper abdomen. The pancreas is disconnected from the nearby gut, and then reconnected to this to allow pancreatic juice containing digestive enzymes to enter the digestive system. A fistula occurs when the reconnection does not heal properly, creating a leak of pancreatic juice from the pancreas to the abdominal tissues. This delays recovery from surgery and often requires further treatment to ensure complete healing. The role of fibrin sealants (surgical tissue adhesives) to reduce postoperative pancreatic fistula after pancreatic surgery is controversial.
Study characteristics
We searched for all relevant, well‐conducted studies up to August 2015. We included nine randomized controlled trials (an experiment in which participants are randomly allocated to two or more interventions, possibly including a control intervention or no intervention, and the results are compared). A total of 1095 participants were randomized either to fibrin sealant group (N = 550) or control group (N = 545) in the nine studies.
Key results
There was no evidence of significant differences in overall postoperative pancreatic fistula (29.6% versus 31.0%), death (3.1% versus 2.1%), complications (29.6% versus 28.9%), reoperation (8.7% versus 10.7%), or duration of hospitalization (12.9 days versus 13.1 days) between fibrin sealant group and control group. Only three trials clearly distinguished significant postoperative pancreatic fistula which required a change in the management of the patient, there was no evidence of significant difference between the two groups (9.4% versus 13.4%). Quality of life and hospital costs in patients were not reported in any of the trials.
Based on the observations in the nine trials included in this review, it appears that fibrin sealants do not prevent postoperative pancreatic fistula in people undergoing pancreatic surgery.
Quality of the evidence
All trials were at high risk of bias (suggesting the possibility of over‐ or under‐estimating the benefits or harms). Overall, the quality of the evidence varied from very low to low.
