Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03658863; https://clinicaltrials.gov/ct2/show/NCT03658863. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18837