Comparing Routine Versus Selective Intraoperative Cholangiography During Gallbladder Surgery to Reduce Complications

What this Trial Is About

This research aims to compare two approaches to intraoperative cholangiography IOC during gallstone surgery for patients without suspicion of common bile duct stones CBDS. Gallstone disease can lead to complications if stones migrate into the bile duct. The study evaluates whether performing IOC routinely or only selectively when there is uncertainty about bile duct anatomy affects the risk of complications like pancreatitis, bleeding, or bile duct injury. It is a national multicenter randomized controlled trial embedded in the Swedish Registry for Gallstone Surgery GallRiks. Participants will be randomly assigned to either routine IOC, where the procedure is attempted in all cases regardless of indication, or selective IOC, where it is only attempted if the anatomy is unclear. Both groups undergo laparoscopic cholecystectomy for gallstone-related disease. The study plans to recruit 6,000 patients and will follow them for one year after surgery to compare outcomes. Secondary measures include procedure time, mortality, hospital stay, quality of life, and healthcare costs. During the study, participants will have data collected through the GallRiks registry, including surgical details and follow-up evaluations at 30 days and one year. Quality of life questionnaires SF-36 and EQ5D will be completed at baseline, 30 days, and one year post-surgery. Researchers will monitor for readmission or reintervention related to the cholecystectomy within 12 months as the primary outcome. Safety and complications will also be tracked through routine patient record review and surgeon consultation when needed.

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