Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.
National Center for Tumor Diseases (NCT), Partner Site Dresden, Heidelberg, Germany.
BJS Open. 2023 Jan 6;7(1). doi: 10.1093/bjsopen/zrac163.
Biliary-enteric anastomosis (BEA) can be performed using continuous or interrupted suture techniques, but high-quality evidence regarding superiority of either technique is lacking. The aim of this study was to compare the suture techniques for patients undergoing BEA by evaluating the suture time as well as short- and long-term biliary complications.
In this single-centre randomized clinical trial, patients scheduled for elective open procedure with a BEA between 21 January 2016 and 20 September 2017 were randomly allocated in a 1:1 ratio to have the BEA performed with continuous suture (CSG) or interrupted suture technique (ISG). The primary outcome was the time required to complete the anastomosis. Secondary outcomes were BEA-associated postoperative complications with and without operative revision of the BEA, including bile leakage, cholestasis, and cholangitis, as well as morbidity and mortality up to day 30 after the intervention and survival.
Altogether, 82 patients were randomized of which 80 patients received the allocated intervention (39 in ISG and 41 in CSG). Suture time was longer in the ISG compared with the CSG (median (interquartile range), 22.4 (15.0-28.0) min versus 12.0 (10.0-17.0) min, OR 1.26, 95 per cent c.i. 1.13 to 1.40; unit of increase of 1 min; P < 0.001). Short-term and long-term biliary complications were similar between groups. The incidence of bile leakage (6 (14.6 per cent) versus 4 (10.3 per cent), P = 0.738) was comparable between groups. No anastomotic stenosis occurred in either group.
Continuous suture of BEA is equally safe, but faster compared with interrupted suture.
NCT02658643 (http://www.clinicaltrials.gov).
胆肠吻合术（BEA）可采用连续或间断缝合技术进行，但缺乏关于任何一种技术优势的高质量证据。本研究旨在通过评估缝合时间以及短期和长期胆道并发症，比较 BEA 患者的缝合技术。
在这项单中心随机临床试验中，2016 年 1 月 21 日至 2017 年 9 月 20 日期间，计划行择期开放手术并进行 BEA 的患者以 1:1 的比例随机分配接受连续缝合（CSG）或间断缝合技术（ISG）进行 BEA。主要结局是完成吻合所需的时间。次要结局是 BEA 相关的术后并发症，包括胆漏、胆汁淤积和胆管炎，以及干预后第 30 天内的发病率和死亡率以及生存情况。
共随机分配了 82 例患者，其中 80 例患者接受了分配的干预措施（ISG 组 39 例，CSG 组 41 例）。ISG 组的缝合时间明显长于 CSG 组（中位数（四分位间距），22.4（15.0-28.0）min 与 12.0（10.0-17.0）min，OR 1.26，95%置信区间 1.13 至 1.40；增加 1min；P<0.001）。两组的短期和长期胆道并发症相似。两组胆漏的发生率（6 例（14.6%）与 4 例（10.3%），P=0.738）相似。两组均未发生吻合口狭窄。
连续缝合 BEA 与间断缝合一样安全，但速度更快。
NCT02658643（http://www.clinicaltrials.gov）。
