Aleknaite Ausra, Simutis Gintaras, Stanaitis Juozas, Jucaitis Tomas, Drungilas Mantas, Valantinas Jonas, Strupas Kestutis
Clinic of Gastroenterology, Nephrourology and Surgery, Institute of Clinical Medicine, Faculty of Medicine of Vilnius University, Vilnius, Lithuania.
Center of Hepatology, Gastroenterology and Dietetics, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
JMIR Res Protoc. 2021 Feb 4;10(2):e18837. doi: 10.2196/18837.
The optimal approach for patients with gallbladder stones and intermediate risk of choledocholithiasis remains undetermined. The use of endoscopic retrograde cholangiopancreatography for diagnosis should be minimized as it carries considerable risk of postprocedural complications, and nowadays, less invasive and safer techniques are available.
This study compares the two management strategies of endoscopic ultrasound before laparoscopic cholecystectomy and intraoperative cholangiography for patients with symptomatic cholecystolithiasis and intermediate risk of choledocholithiasis.
This is a randomized, active-controlled, single-center clinical trial enrolling adult patients undergoing laparoscopic cholecystectomy for symptomatic gallbladder stones with intermediate risk of choledocholithiasis. The risk of choledocholithiasis is calculated using an original prognostic score (the Vilnius University Hospital Index). This index in a retrospective evaluation showed better prognostic performance than the score proposed by the American Society for Gastrointestinal Endoscopy in 2010. A total of 106 participants will be included and randomized into two groups. Evaluation of bile ducts using endoscopic ultrasound and endoscopic retrograde cholangiography on demand will be performed before laparoscopic cholecystectomy for one arm ("endoscopy first"). Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative endoscopic retrograde cholangiopancreatography on demand will be performed in another arm ("cholecystectomy first"). Postoperative follow-up is 6 months. The primary endpoint is the length of hospital stay. The secondary endpoints are accuracy of the different management strategies, adverse events of the interventions, duct clearance and technical success of the interventions (intraoperative cholangiography, endoscopic ultrasound, and endoscopic retrograde cholangiography), and cost of treatment.
The trial protocol was approved by the Vilnius Regional Biomedical Research Ethics Committee in December 2017. Enrollment of patients was started in January 2018. As of June 2020, 66 patients have been enrolled.
This trial is planned to determine the superior strategy for patients with intermediate risk of common bile duct stones and to define a simple and safe algorithm for managing choledocholithiasis.
ClinicalTrials.gov NCT03658863; https://clinicaltrials.gov/ct2/show/NCT03658863.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18837.
对于有胆囊结石且患胆总管结石中度风险的患者，最佳治疗方法仍未确定。由于内镜逆行胰胆管造影术存在相当大的术后并发症风险，应尽量减少其用于诊断的情况，而且如今已有侵入性较小且更安全的技术。
本研究比较了有症状胆囊结石且患胆总管结石中度风险的患者在腹腔镜胆囊切除术前行内镜超声检查和术中胆管造影这两种治疗策略。
这是一项随机、阳性对照、单中心临床试验，纳入因有症状胆囊结石且患胆总管结石中度风险而接受腹腔镜胆囊切除术的成年患者。使用一种原始的预后评分（维尔纽斯大学医院指数）来计算胆总管结石的风险。该指数在一项回顾性评估中显示出比美国胃肠内镜学会2010年提出的评分更好的预后表现。总共将纳入106名参与者并随机分为两组。一组（“先进行内镜检查”）在腹腔镜胆囊切除术前行内镜超声检查并按需进行内镜逆行胰胆管造影术以评估胆管。另一组（“先进行胆囊切除术”）在腹腔镜胆囊切除术期间进行术中胆管造影并在术后按需进行内镜逆行胰胆管造影术。术后随访6个月。主要终点是住院时间。次要终点是不同治疗策略的准确性、干预的不良事件、胆管清理情况以及干预（术中胆管造影、内镜超声检查和内镜逆行胰胆管造影术）的技术成功率和治疗费用。
试验方案于2017年12月获得维尔纽斯地区生物医学研究伦理委员会批准。患者招募于2018年1月开始。截至2020年6月，已招募66名患者。
本试验计划确定患胆总管结石中度风险患者的更佳策略，并确定一种简单且安全的胆总管结石管理算法。
ClinicalTrials.gov NCT03658863；https://clinicaltrials.gov/ct2/show/NCT03658863。
国际注册报告识别码（IRRID）：DERR1-10.2196/18837。
