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Safety and performance of a synthetic sealant patch aimed to prevent postoperative pancreatic fistula after distal pancreatectomy (SHIELDS) – Prospective international multicenter phase II study.
- Source :
-
HPB . Jul2024, Vol. 26 Issue 7, p903-910. 8p. - Publication Year :
- 2024
-
Abstract
- 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. 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. 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. 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PANCREATECTOMY
*PANCREATIC fistula
*SEALING compounds
*SURGICAL excision
Subjects
Details
- Language :
- English
- ISSN :
- 1365182X
- Volume :
- 26
- Issue :
- 7
- Database :
- Academic Search Index
- Journal :
- HPB
- Publication Type :
- Academic Journal
- Accession number :
- 177877268
- Full Text :
- https://doi.org/10.1016/j.hpb.2024.03.002