ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A National Registry-based Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the risks and benefits of performing intraoperative cholangiography (IOC) routinely versus selectively during gallstone surgery in patients without suspicion of common bile duct stones (CBDS). This national multicenter randomized controlled trial aims to provide clearer evidence on whether routine IOC reduces complications such as pancreatitis, obstructive jaundice, or cholangitis compared to selective IOC, which is performed only when bile duct anatomy is unclear during surgery. The study addresses an important knowledge gap in gallstone surgery practices internationally. Participants will be randomly assigned to one of two groups: routine IOC, where the procedure is attempted regardless of indication or anatomy, or selective IOC, where it is done only if there is uncertainty about the bile duct anatomy. The trial is embedded in the Swedish Registry for Gallstone Surgery and will include about 6,000 patients undergoing laparoscopic cholecystectomy. Patients with preoperative suspicion of CBDS or other related conditions are excluded. The study will follow participants for 12 months after surgery to monitor for complications. During the study, patients will be monitored for readmissions or need for reinterventions related to the surgery within one year. Data collected will include procedure time, mortality rates, hospital stay length, and patient quality of life measured by standard questionnaires at baseline, 30 days, six months, and one year after surgery. The trial uses registry data and routine follow-up visits to track outcomes, aiming to evaluate the overall morbidity related to the different IOC approaches.

ChOlanGiography Performed Routinely Versus Selectively During Cholecystectomy: A NAtional Registry-based Randomized Controlled Trial