BACKGROUND The pancreatic transection method during distal pancreatectomy is thought to influence postoperative fistula rates. Yet, the optimal technique for minimizing fistula occurrence is still unclear. The present randomized controlled trial compared stapled versus ultrasonic transection in elective distal pancreatectomy. METHODS Patients undergoing distal pancreatectomy from July 2018 to July 2020 at two high-volume institutions were considered for inclusion. Exclusion criteria were contiguous organ resection and a parenchymal thickness > 17 mm on intraoperative ultrasound. Eligible patients were randomized in a 1:1 ratio to stapled transection (Endo GIA Reinforced Reload with Tri-Staple Technology®) or ultrasonic transection (Harmonic Focus® + or Harmonic Ace® + shears). The primary endpoint was postoperative pancreatic fistula. Secondary endpoints included overall complications, abdominal collections, and length of hospital stay. RESULTS Overall, 72 patients were randomized in the stapled transection arm and 73 patients in the ultrasonic transection arm. Postoperative pancreatic fistula occurred in 23 patients (16%), with a comparable incidence between groups (12% in stapled transection versus 19% in ultrasonic dissection arm, p = 0.191). Overall complications did not differ substantially (35% in stapled transection versus 44% in ultrasonic transection arm, p = 0.170). There was an increased incidence of abdominal collections in the ultrasonic dissection group (32% versus 14%, p = 0.009), yet the need for percutaneous drain did not differ between randomization arms (p = 0.169). The median length of stay was 8 days in both groups (p = 0.880). Intraoperative blood transfusion was the only factor independently associated with postoperative pancreatic fistula on logistic regression analysis (OR 4.8, 95% CI 1.2-20.0, p = 0.032). CONCLUSION The present randomized controlled trial of stapled versus ultrasonic transection in elective distal pancreatectomy demonstrated no significant difference in postoperative pancreatic fistula rates and no substantial clinical impact on other secondary endpoints.

中文翻译：

---

远端胰腺切除术中吻合与超声横断的随机对照试验。

背景 远端胰腺切除术中的胰腺横切方法被认为会影响术后瘘管发生率。然而，减少瘘管发生的最佳技术仍不清楚。本随机对照试验比较了择期远端胰腺切除术中的吻合器与超声横断术。方法 2018 年 7 月至 2020 年 7 月在两个高容量机构接受远端胰腺切除术的患者被考虑纳入。排除标准是邻近器官切除和术中超声显示的实质厚度> 17 mm。符合条件的患者以 1:1 的比例随机分配到吻合器横断术（Endo GIA Reinforced Reload with Tri-Staple Technology®）或超声横断术（Harmonic Focus® + 或 Harmonic Ace® + 剪刀）。主要终点是术后胰瘘。次要终点包括总体并发症、腹部收集物和住院时间。结果 总体而言，72 名患者被随机分配到吻合器横断组，73 名患者随机分配到超声横断组。术后胰瘘发生在 23 名患者 (16%) 中，组间发生率相当（吻合器横断组为 12%，超声解剖组为 19%，p = 0.191）。总体并发症没有显着差异（吻合器横断为 35%，超声横断臂为 44%，p = 0.170）。超声剥离组的腹部积液发生率增加（32% 对 14%，p = 0.009），但经皮引流的需要在随机组之间没有差异（p = 0.169）。两组的中位住院时间均为 8 天 (p = 0.880)。在逻辑回归分析中，术中输血是唯一与术后胰瘘独立相关的因素 (OR 4.8, 95% CI 1.2-20.0, p = 0.032)。结论 本随机对照试验表明，在选择性远端胰腺切除术中，缝合器与超声横断术在术后胰瘘发生率上没有显着差异，对其他次要终点也没有实质性临床影响。