Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Feb 10;2(1):e033.
doi: 10.1097/AS9.0000000000000033. eCollection 2021 Mar.

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

Selman Uranues  1 , Abraham Fingerhut  1   2 , Orlin Belyaev  3 , Alessandro Zerbi  4 , Ugo Boggi  5 , Matthias W Hoffmann  6 , Daniel Reim  7 , Alessandro Esposito  8 , Florian Primavesi  9   10 , Peter Kornprat  11 , Roberto Coppola  12 , Georgio P Fragulidis  13 , Mario Serradilla-Martin  14 , Orhan Alimoglu  15 , Andrea Peri  16 , Bogdan Diaconescu  17
Affiliations

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

Selman Uranues et al. Ann Surg Open. .

Abstract

Introduction: 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.

Material and methods: 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.

Results: 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% (P = 0.120), while the number of patients with 1 or more complications (including patients with B/C POPF) was 34.8% and 24.4% (P = 0.049) in the standard and Hemopatch groups, respectively. In patients with hand-sewn stump and main duct closure, the rates were 26.2% versus 10.0% (P = 0.014) and 23.3% versus 7.7% (P = 0.015) in the standard and Hemopatch groups, respectively. The NNT in these 2 subgroups was 6 and 6.4, respectively.

Conclusion: 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.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

FIGURE 1.
FIGURE 1.
Hemopatch covering a hand-sewn pancreatic stump closure.
FIGURE 2.
FIGURE 2.
CONSORT flow chart.
See this image and copyright information in PMC

References

    1. Diener MK, Seiler CM, Rossion I, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011; 377:1514–1522 - PubMed
    1. Eshmuminov D, Schneider MA, Tschuor C, et al. Systematic review and meta-analysis of postoperative pancreatic fistula rates using the updated 2016 International Study Group Pancreatic Fistula definition in patients undergoing pancreatic resection with soft and hard pancreatic texture. HPB (Oxford). 2018; 20:992–1003 - PubMed
    1. Jang JY, Shin YC, Han Y, et al. Effect of polyglycolic acid mesh for prevention of pancreatic fistula following distal pancreatectomy: a randomized clinical trial. JAMA Surg. 2017; 152:150–155 - PubMed
    1. Nahm CB, Connor SJ, Samra JS, et al. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018; 11:105–118 - PMC - PubMed
    1. Merkow RP, Bilimoria KY, Tomlinson JS, et al. Postoperative complications reduce adjuvant chemotherapy use in resectable pancreatic cancer. Ann Surg. 2014; 260:372–377 - PubMed