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.

中文翻译：

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旨在预防远端胰腺切除术后胰瘘 (SHIELDS) 的合成密封剂补片的安全性和性能 – 前瞻性国际多中心 II 期研究

远端胰腺切除术 (DP) 中临床相关的术后胰瘘 (CR-POPF) 的发生率高达 25%。现有的密封剂均无法显着降低 CR-POPF。一种新型可生物降解密封剂贴片能够减少 POPF 并在临床前猪 DP 模型中实现出血控制。这项首次人体研究的目的是评估密封剂贴片的安全性和性能。在这项多中心、单臂研究中，前瞻性地招募了来自 8 个中心的 40 名接受远端胰腺切除术的患者。手术切除后，根据护理标准关闭横断平面，并用密封剂贴片手动覆盖。作为主要终点，评估术后 30 天的 CR-POPF 发生率。次要终点包括并发症和设备可用性的评估。在 40 例远端胰腺切除术后患者中，截至术后第 30 天，7 例（17.5%）发生 CR-POPF。未观察到 C 型 POPF。应用补片后未观察到术中出血。这项国际 II 期研究的结果表明，新型密封剂贴片在 CR-POPF 率方面取得了良好的结果。现在需要进行随机研究来确认当前补丁与当前最佳实践相比的优越性。