Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.
Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, 230022, Anhui, China.
Trials. 2020 Jun 29;21(1):586. doi: 10.1186/s13063-020-04483-z.
Residual and recurrent stones remain one of the most important challenges of hepatolithiasis and are reported in 20 to 50% of patients treated for this condition. To date, the two most common surgical procedures performed for hepatolithiasis are choledochojejunostomy and T-tube drainage for biliary drainage. The goal of the present study was to evaluate the therapeutic safety and perioperative and long-term outcomes of choledochojejunostomy versus T-tube drainage for hepatolithiasis patients with sphincter of Oddi laxity (SOL).
METHODS/DESIGN: In total, 210 patients who met the following eligibility criteria were included and were randomized to the choledochojejunostomy arm or T-tube drainage arm in a 1:1 ratio: (1) diagnosed with hepatolithiasis with SOL during surgery; (2) underwent foci removal, stone extraction and stricture correction during the operation; (3) provided written informed consent; (4) was willing to complete a 3-year follow-up; and (5) aged between 18 and 70 years. The primary efficacy endpoint of the trial will be the incidence of biliary complications (stone recurrence, biliary stricture, cholangitis) during the 3 years after surgery. The secondary outcomes will be the surgical, perioperative and long-term follow-up outcomes.
This is a prospective, single-centre and randomized controlled two-group parallel trial designed to demonstrate which drainage method (Roux-en-Y hepaticojejunostomy or T-tube drainage) can better reduce biliary complications (stone recurrence, biliary stricture, cholangitis) in hepatolithiasis patients with SOL.
Clinical Trials.gov: NCT04218669 . Registered on 6 January 2020.
残余和复发性结石仍然是肝胆管结石的最重要挑战之一，在接受这种治疗的患者中，有 20%至 50%报告存在此类问题。迄今为止，肝胆管结石最常采用的两种手术方法是胆肠吻合术和 T 管引流术以进行胆汁引流。本研究的目的是评估胆肠吻合术与 T 管引流术治疗胆道口括约肌松弛（Oddi 括约肌松弛）的肝胆管结石患者的治疗安全性以及围手术期和长期疗效。
方法/设计：共有 210 名符合以下入选标准的患者被纳入研究，并按 1:1 的比例随机分配至胆肠吻合术组或 T 管引流术组：（1）手术中诊断为胆道口括约肌松弛伴肝胆管结石；（2）手术中进行了病灶切除、结石取出和狭窄矫正；（3）签署了书面知情同意书；（4）愿意完成 3 年随访；（5）年龄在 18 至 70 岁之间。试验的主要疗效终点将是术后 3 年内的胆道并发症（结石复发、胆道狭窄、胆管炎）发生率。次要结局将是手术、围手术期和长期随访结局。
这是一项前瞻性、单中心、随机对照两臂平行试验，旨在证明哪种引流方法（Roux-en-Y 胆肠吻合术或 T 管引流术）能更好地降低胆道口括约肌松弛的肝胆管结石患者的胆道并发症（结石复发、胆道狭窄、胆管炎）发生率。
ClinicalTrials.gov：NCT04218669。于 2020 年 1 月 6 日注册。
