Clinical Impact of Stump Closure Reinforced With Hemopatch on the Prevention of Clinically Relevant Pancreatic Fistula After Distal Pancreatectomy: A Multicenter Randomized Trial.

Postoperative pancreatic fistula (POPF) is the most dreaded complication after distal pancreatectomy (DP). This multicenter randomized trial evaluated the efficacy, safety, and tolerance of Hemopatch in preventing clinically relevant (grades B/C according to the ISGPS classification) POPF after DP. After stump closure, patients were randomized to affix Hemopatch to the stump or not. Statistical significance was set at 0.025. Clinical significance was defined as the number of patients needed to treat (NNT) to avoid 1 B/C POPF. Of 631 eligible patients, 360 were randomized and 315 analyzed per protocol (155 in the standard closure group; 160 in the Hemopatch group). The rates of B/C POPF (the primary endpoint) were 23.2% and 16.3% ( The results of the first randomized trial evaluating Hemopatch-reinforced pancreatic stump after DP to prevent type B/C POPF do not allow us to conclude that the risk of B/C POPF was lower. Based on the NNT, however, routine use of Hemopatch after DP may result in fewer complications (including POPF) overall, especially in cases with hand-sewn closure of the pancreatic stump or main pancreatic duct.

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Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Déclaration de conflit d'intérêts

All authors have contributed either to the conception, drafting, and critical revision of this manuscript and have given their approval of its contents. The authors acknowledge the help of Chadl Dziri, MD, FACS (Tunis University El Manar—Medical School of Tunis; Director of Honoris Medical Simulation Center—Tunis) in the analysis of data. None of the authors have any conflicts of interest, financial or otherwise, to disclose and declare that Industry had no role in data acquisition, analysis, or the writing of this article.