Uranues Selman, Fingerhut Abraham, Belyaev Orlin, Zerbi Alessandro, Boggi Ugo, Hoffmann Matthias W, Reim Daniel, Esposito Alessandro, Primavesi Florian, Kornprat Peter, Coppola Roberto, Fragulidis Georgio P, Serradilla-Martin Mario, Alimoglu Orhan, Peri Andrea, Diaconescu Bogdan
From the Section for Surgical Research, Department of Surgery, Medical University of Graz, Graz, Austria.
Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Minimally Invasive Surgery Center, Shanghai, P. R. China.
Ann Surg Open. 2021 Feb 10;2(1):e033. doi: 10.1097/AS9.0000000000000033. eCollection 2021 Mar.
Postoperative pancreatic fistula (POPF) is the most dreaded complication after distal pancreatectomy (DP). This multicenter randomized trial evaluated the efficacy, safety, and tolerance of Hemopatch in preventing clinically relevant (grades B/C according to the ISGPS classification) POPF after DP.
After stump closure, patients were randomized to affix Hemopatch to the stump or not. Statistical significance was set at 0.025. Clinical significance was defined as the number of patients needed to treat (NNT) to avoid 1 B/C POPF.
Of 631 eligible patients, 360 were randomized and 315 analyzed per protocol (155 in the standard closure group; 160 in the Hemopatch group). The rates of B/C POPF (the primary endpoint) were 23.2% and 16.3% ( = 0.120), while the number of patients with 1 or more complications (including patients with B/C POPF) was 34.8% and 24.4% ( = 0.049) in the standard and Hemopatch groups, respectively. In patients with hand-sewn stump and main duct closure, the rates were 26.2% versus 10.0% ( = 0.014) and 23.3% versus 7.7% ( = 0.015) in the standard and Hemopatch groups, respectively. The NNT in these 2 subgroups was 6 and 6.4, respectively.
The results of the first randomized trial evaluating Hemopatch-reinforced pancreatic stump after DP to prevent type B/C POPF do not allow us to conclude that the risk of B/C POPF was lower. Based on the NNT, however, routine use of Hemopatch after DP may result in fewer complications (including POPF) overall, especially in cases with hand-sewn closure of the pancreatic stump or main pancreatic duct.
术后胰瘘（POPF）是胰体尾切除术（DP）后最可怕的并发症。这项多中心随机试验评估了Hemopatch在预防DP术后临床相关（根据国际胰腺外科研究组分类为B/C级）POPF方面的疗效、安全性和耐受性。
在残端闭合后，将患者随机分为在残端粘贴Hemopatch与否两组。统计学显著性设定为0.025。临床显著性定义为避免1例B/C级POPF所需治疗的患者数量（NNT）。
在631例符合条件的患者中，360例被随机分组，315例按方案进行分析（标准闭合组155例；Hemopatch组160例）。标准组和Hemopatch组的B/C级POPF（主要终点）发生率分别为23.2%和16.3%（P = 0.120），而有1种或更多并发症（包括B/C级POPF患者）的患者比例分别为34.8%和24.4%（P = 0.049）。在手工缝合残端和主胰管闭合的患者中，标准组和Hemopatch组的发生率分别为26.2%对10.0%（P = 0.014）和23.3%对7.7%（P = 0.015）。这两个亚组的NNT分别为6和6.4。
第一项评估DP术后使用Hemopatch加固胰残端以预防B/C级POPF的随机试验结果，无法让我们得出B/C级POPF风险更低的结论。然而，基于NNT，DP术后常规使用Hemopatch可能总体上减少并发症（包括POPF）的发生，尤其是在胰残端或主胰管手工缝合的情况下。
