Article type
Year
Abstract
Background: Appropriate closure of the pancreatic remnant after distal pancreatectomy is still debated. A variety of procedures have been recommended to reduce the frequency of pancreatic fistula. A systematic review and meta-analysis of the existing literature was performed to compare the available techniques regarding postoperative mortality and morbidity respectively. Subsequently, a study protocol was developed in order to generate high-level evidence in a multicenter randomized-controlled trial.
Methods: Original articles and abstracts published until the end of June 2004 were searched without language restrictions in the Cochrane Controlled Trials Register, Medline and Embase. Three reviewers independently assessed each study's eligibility, quality and extracted the data. A random effects model was performed using weighted odds ratios. A study protocol according to the standards of GCP was developed on the basis of the pooled and quantified data.
Results: Only ten of 262 articles could be included, two randomized clinical trials and eight observational studies. Reported postoperative morbidity varied from 13.3 to 64 per cent. The primary outcome measure, pancreatic fistula rate, occurred within the range of 0 - 64.3 per cent. Meta-analysis of the six studies comparing stapler versus hand-sutured closure showed a non significant combined odds ratio for occurrence of a pancreatic fistula of 0.66 (95 % confidence interval 0.35 to 1.26, P = 0.21) in favour of stapler-closure.
Conclusions: On the basis of these data the Study Centre of the German Surgical Society plans to conduct a RCT comparing stapler-closure versus hand-sewn closure of the pancreatic stump following distal pancreatectomy. The DISPACT Â TRIAL is planned as a multi-centered, intra-operatively randomized and patient-blinded RCT performed in a two-group paralleled adaptive superiority design. 151 patients in each group will be recruited in up to 20 centers of excellence in order to assess the primary endpoint: pancreatic fistula and death. A standardized surgical technique and follow-up will provide a valid predication of a potential superiority of one technique.
Methods: Original articles and abstracts published until the end of June 2004 were searched without language restrictions in the Cochrane Controlled Trials Register, Medline and Embase. Three reviewers independently assessed each study's eligibility, quality and extracted the data. A random effects model was performed using weighted odds ratios. A study protocol according to the standards of GCP was developed on the basis of the pooled and quantified data.
Results: Only ten of 262 articles could be included, two randomized clinical trials and eight observational studies. Reported postoperative morbidity varied from 13.3 to 64 per cent. The primary outcome measure, pancreatic fistula rate, occurred within the range of 0 - 64.3 per cent. Meta-analysis of the six studies comparing stapler versus hand-sutured closure showed a non significant combined odds ratio for occurrence of a pancreatic fistula of 0.66 (95 % confidence interval 0.35 to 1.26, P = 0.21) in favour of stapler-closure.
Conclusions: On the basis of these data the Study Centre of the German Surgical Society plans to conduct a RCT comparing stapler-closure versus hand-sewn closure of the pancreatic stump following distal pancreatectomy. The DISPACT Â TRIAL is planned as a multi-centered, intra-operatively randomized and patient-blinded RCT performed in a two-group paralleled adaptive superiority design. 151 patients in each group will be recruited in up to 20 centers of excellence in order to assess the primary endpoint: pancreatic fistula and death. A standardized surgical technique and follow-up will provide a valid predication of a potential superiority of one technique.