Department of General Surgery, University Hospital of Friedrich-Alexander-University, Krankenhausstraße 12, Erlangen, Germany.
Department of General Surgery, University Hospital Greifswald, Ferdinand-Sauerbruch-Straße, Greifswald, Germany.
Trials. 2022 Jun 6;23(1):467. doi: 10.1186/s13063-022-06427-1.
Hepaticojejunostomy is commonly performed in hepato-bilio-pancreatic surgery, particularly during pancreaticoduodenectomy. The purpose of this study is to evaluate the safety and efficiency of two commonly applied suture techniques (the interrupted versus the continuous suture technique) in patients undergoing a hepaticojejunostomy during pancreatoduodenectomy.
The HEKTIK trial is a multicenter, randomized controlled, patient-blinded surgical explorative trial with two parallel study groups. An adaptive sample size design was chosen: First, 100 patients scheduled for surgery including a hepaticojejunostomy will be randomized 1:1 either to the interrupted suture technique or the continuous suture technique after informed consent. Based on this data, needed sample size will be adjusted. The primary endpoint will be the occurrence of anastomotic leakage of hepaticojejunostomy, defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis (according to the definition of ISGLS). Further perioperative parameters like other morbidities as well as duration and costs of the hepaticojejunostomy will be analyzed as secondary outcomes.
Until now there are no randomized controlled comparative data of these two suture techniques for hepaticojejunostomy. The HEKTIK trial will investigate the yet unanswered question of whether the interrupted suture or the continuous suture technique has advantages performing a hepaticojejunostomy during pancreatoduodenectomy.
German Clinical Trials Register DRKS00024395 . Registered on 01 February 2021.
肝胆管空肠吻合术在肝胆胰脾外科中普遍施行，尤其在胰十二指肠切除术时。本研究旨在评估两种常用缝合技术（间断缝合技术与连续缝合技术）在胰十二指肠切除术中行肝胆管空肠吻合术患者中的安全性和效率。
HEKTIK 试验是一项多中心、随机对照、患者设盲的外科探索性试验，有两个平行的研究组。选择适应性样本量设计：首先，将 100 例计划手术包括肝胆管空肠吻合术的患者在知情同意后，按 1:1 随机分为间断缝合技术组或连续缝合技术组。基于这些数据，将调整所需样本量。主要终点是肝胆管空肠吻合术吻合口漏的发生，定义为术后第 3 天或之后引流液中胆红素浓度至少为血清胆红素浓度的 3 倍，或因胆汁积聚或胆汁性腹膜炎需要进行放射学或手术干预（根据 ISGLS 的定义）。还将分析其他围手术期参数，如其他并发症，以及肝胆管空肠吻合术的持续时间和成本作为次要结局。
到目前为止，还没有这两种缝合技术用于肝胆管空肠吻合术的随机对照比较数据。HEKTIK 试验将研究这两种缝合技术在胰十二指肠切除术中行肝胆管空肠吻合术时是否具有优势的尚未回答的问题。
德国临床试验注册中心 DRKS00024395。于 2021 年 2 月 1 日注册。
