A Randomized Trial of One vs. Two Transpapillary Cystic Duct Stents to Prevent Recurrent Symptomatic Gallbladder Disease in Non-Cholecystectomy Candidates

What this Trial Is About

Researchers are evaluating whether placing two cystic duct stents is more effective than one stent in preventing recurrent gallbladder disease such as cholecystitis, gallstone pancreatitis, or biliary colic. This trial focuses on patients who are not immediate candidates for gallbladder removal surgery. The study aims to compare the safety and success rates of these two approaches, including rates of recurrent gallbladder disease and procedure-related complications. Participants will undergo an endoscopic retrograde cholangiopancreatography (ERCP), an endoscopic procedure where a guidewire is passed into the bile duct from the small intestine. They will be randomly assigned to receive either one or two transpapillary cystic duct stents placed into the gallbladder. Both groups will receive standard care after the procedure and will be monitored for any recurrent symptoms or complications. During the study, participants will be evaluated for eligibility and provide consent before the ERCP. Follow-up assessments will track clinical success over six months, technical success of stent placement within one day, time to recurrence of symptoms, need for reintervention, and any adverse events. Researchers will use these outcomes to determine which stenting strategy offers better long-term gallbladder drainage and fewer recurrent events.

One vs. Two Stents for Gallbladder Disease