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).

中文翻译：

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PATCH-DP：一项单臂 II 期试验，将 HEMOPATCH™ 术中应用于胰腺残端，以预防胰腺远端切除术后的术后胰瘘

背景

术后胰瘘 (POPF) 是远端胰腺切除术后发病的最重要原因。Hemopatch™ 是一种薄的、基于牛胶原蛋白的止血密封剂。我们假设在远端胰腺切除术后将 Hemopatch™ 应用于胰腺残端会降低临床显着 POPF 的发生率。

方法

我们进行了一项前瞻性、单臂、多中心 II 期研究，将 Hemopatch™ 应用于胰腺远端切除术后的胰腺残端。主要结果是手术后 90 天内有临床意义的 POPF。需要 52 名患者的样本量来证明 B/C 级 POPF 从 20% 的基线发生率相对降低 50%，I 型错误为 0.2，功效为 0.75。次要结局包括 POPF 的发生率（所有级别）、90 天死亡率、90 天发病率、再次干预和住院时间。

结果

在所有病例中，Hemopatch™ 充分固定到胰腺残端都是成功的。B/C 级 POPF 率为 25%（95%CI：14.0-39.0%）。与历史基线相比，B/C 级 POPF 的发生率没有显着差异（p = 0.46）。Clavien-Dindo ≥3 级并发症的 90 天发生率为 26.9%（95%CI：15.6-41.0%）。

结论

与历史发生率相比，使用 Hemopatch™ 与临床显着 POPF 发生率的降低无关。

（NCT03410914）。