Safety and performance of a synthetic sealant patch aimed to prevent postoperative pancreatic fistula after distal pancreatectomy (SHIELDS) - Prospective international multicenter phase II study.

Autor:	Goetz MR; Department of General, Visceral and Thoracic Surgery, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany., Heumann A; Department of General, Visceral and Thoracic Surgery, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany., Bassi C; Department of Surgery, Pancreas Institute, Verona University Hospital, Verona, Italy., Landoni L; Department of Surgery, Pancreas Institute, Verona University Hospital, Verona, Italy., Khatib-Chahidi K; Department for General- and Visceral Surgery, University Hospital Oldenburg, Oldenburg, Germany., Ghadimi M; Department of General, Visceral, and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany., von Heessen M; Department of General, Visceral, and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany., Berrevoet F; Department of General and Hepatopancreatobiliary Surgery and Liver Transplantation, Ghent University Hospital, Ghent, Belgium., Gryspeerdt F; Department of General and Hepatopancreatobiliary Surgery and Liver Transplantation, Ghent University Hospital, Ghent, Belgium., Besselink M; Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, the Netherlands; Cancer Center Amsterdam, Amsterdam, the Netherlands., van Bodegraven EA; Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Amsterdam, the Netherlands; Cancer Center Amsterdam, Amsterdam, the Netherlands., Adham M; Department of Digestive, Hepato-Biliary and Pancreatic Surgery, Edouard Herriot Hospital, Lyon, France., Pratschke J; Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Charité- Universitätsmedizin Berlin, Berlin, Germany., Schöning W; Department of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Charité- Universitätsmedizin Berlin, Berlin, Germany., Izbicki JR; Department of General, Visceral and Thoracic Surgery, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany., Bockhorn M; Department for General- and Visceral Surgery, University Hospital Oldenburg, Oldenburg, Germany. Electronic address: maximilian.bockhorn@uni-oldenburg.de.
Jazyk:	angličtina
Zdroj:	HPB : the official journal of the International Hepato Pancreato Biliary Association [HPB (Oxford)] 2024 Jul; Vol. 26 (7), pp. 903-910. Date of Electronic Publication: 2024 Mar 11.
DOI:	10.1016/j.hpb.2024.03.002
Abstrakt:	Objective: The incidence for clinically relevant postoperative pancreatic fistulas (CR-POPF) in distal pancreatectomy (DP) ranges up to 25%. None of the available sealants significantly reduce CR-POPF. A new biodegradable sealant patch was able to reduce POPF and to achieve bleeding control in a preclinical porcine DP model. The aim of this first-in-human study was to assess the safety and performance of the sealant patch. Methods: In this multicenter, single-arm study, 40 patients undergoing distal pancreatectomy were prospectively enrolled from 8 centers. Following surgical resection, the transection plane was closed according to the standard of care and manually covered with the sealant patch. As primary endpoint the incidence of CR-POPF up to 30-days postoperatively was evaluated. The secondary endpoints included the assessment of complications and device usability. Results: Among 40 patients after distal pancreatectomy, CR-POPF occurred in 7 (17.5%) up to postoperative day 30. No type C POPF was observed. There was no intraoperative bleeding observed after patch application. Conclusion: The results of this international phase II study demonstrate promising results of a new sealant patch regarding the rate of CR-POPF. Randomized studies are now needed to confirm the superiority of the current patch as compared to the best current practice. Competing Interests: Conflict of interest Financial support as well as the sealant patches were provided by Polyganics BV. In addition, Maximilian Bockhorn, Asmus Heumann and Jakob R. Izbicki received consulting fees from Polyganics BV. (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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