PATCH-DP 研究：一项术中应用 HEMOPATCH™ 封闭胰腺残端以预防远端胰腺切除术后胰瘘的单臂 II 期临床试验。

PATCH-DP: a single-arm phase II trial of intra-operative application of HEMOPATCH™ to the pancreatic stump to prevent post-operative pancreatic fistula following distal pancreatectomy.

机构信息

Division of General Surgery, Department of Surgery, University of Toronto, Toronto, Canada.

Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Canada.

出版信息

HPB (Oxford). 2022 Jan;24(1):72-78. doi: 10.1016/j.hpb.2021.05.007. Epub 2021 Jun 9.

DOI:10.1016/j.hpb.2021.05.007

PMID:34176743

Abstract

BACKGROUND

Post-operative pancreatic fistula (POPF) is the most significant cause of morbidity following distal pancreatectomy. Hemopatch™ is a thin, bovine collagen-based hemostatic sealant. We hypothesized that application of Hemopatch™ to the pancreatic stump following distal pancreatectomy would decrease the incidence of clinically-significant POPF.

METHODS

We conducted a prospective, single-arm, multicentre phase II study of application of Hemopatch™ to the pancreatic stump following distal pancreatectomy. The primary outcome was clinically-significant POPF within 90 days of surgery. A sample size of 52 patients was required to demonstrate a 50% relative reduction in Grade B/C POPF from a baseline incidence of 20%, with a type I error of 0.2 and power of 0.75. Secondary outcomes included incidence of POPF (all grades), 90-day mortality, 90-day morbidity, re-interventions, and length of stay.

RESULTS

Adequate fixation Hemopatch™ to the pancreatic stump was successful in all cases. The rate of grade B/C POPF was 25% (95%CI: 14.0-39.0%). There was no significant difference in the incidence of grade B/C POPF compared to the historical baseline (p = 0.46). The 90-day incidence of Clavien-Dindo grade ≥3 complications was 26.9% (95%CI: 15.6-41.0%).

CONCLUSION

The use of Hemopatch™ was not associated with a decreased incidence of clinically-significant POPF compared to historical rates. (NCT03410914).

摘要

背景

术后胰腺瘘（POPF）是胰体尾切除术后发病率最高的原因。Hemopatch™ 是一种薄的、基于牛胶原蛋白的止血密封剂。我们假设在胰体尾切除术后将 Hemopatch™ 应用于胰腺残端会降低临床上显著的 POPF 的发生率。

方法

我们进行了一项前瞻性、单臂、多中心的 II 期研究，即在胰体尾切除术后将 Hemopatch™ 应用于胰腺残端。主要结局是手术后 90 天内临床上显著的 POPF。需要 52 例患者的样本量，以显示从 20%的基线发生率降低 50%的 Grade B/C POPF，I 型错误为 0.2，效力为 0.75。次要结局包括 POPF（所有等级）、90 天死亡率、90 天发病率、再次干预和住院时间。

结果

Hemopatch™ 成功固定在胰腺残端的比例为 100%。Grade B/C POPF 的发生率为 25%（95%CI：14.0-39.0%）。与历史基线相比，Grade B/C POPF 的发生率无显著差异（p=0.46）。Clavien-Dindo 分级≥3 级并发症的 90 天发生率为 26.9%（95%CI：15.6-41.0%）。