Randomized Multicentre Double-blind Clinical Trial Comparing ERCP versus ERCP and Transmural Gallbladder Drainage in Non-Surgical Patients with Symptomatic Choledocholithiasis

What this Trial Is About

Cholelithiasis affects 10-20% of the general population, with up to 18% experiencing symptoms such as acute cholangitis, obstructive jaundice, or biliary colic. This trial investigates whether adding transmural gallbladder drainage to ERCP (endoscopic retrograde cholangiopancreatography) reduces hospital admissions due to biliary disease in patients over 75 years old who have symptomatic choledocholithiasis and are not candidates for surgery. The study also aims to assess technical success rates, complications, mortality, and hospital costs over one year. Participants will be randomly assigned to one of two groups: one receiving ERCP with biliary sphincterotomy alone, and the other receiving ERCP with sphincterotomy plus transmural gallbladder drainage via a lumen-apposing metal stent (LAMS) placed endoscopically. The drainage procedure is performed during the same endoscopic session using ultrasound guidance and X-rays. Both groups undergo sedation with propofol and CO2 insufflation during the procedures. Follow-up will last one year, with multiple visits and phone calls scheduled to monitor progress and confirm stent position by ultrasound. Patients will attend four face-to-face visits at 1 day, 3 months, 6 months, and 12 months after the procedure, plus two phone calls at 7 days and 9 months. Clinical outcomes such as hospital readmissions for biliary causes, technical success, mortality, and healthcare costs will be tracked. The study is double-blind, so treating physicians and follow-up staff will not know which treatment was assigned. Adverse events will be monitored and classified according to established guidelines. Data will be anonymized and securely stored for analysis.

Clinical Trial Comparing ERCP vs ERCP and Transmural Gall Bladder Drainage