CBD Stenting vs Non-Stenting for Choledocholithiasis (NCT07331142) | Clinical Trial Compass
CompletedNot Applicable
CBD Stenting vs Non-Stenting for Choledocholithiasis
Egypt200 participantsStarted 2024-03-01
Plain-language summary
The role of prophylactic biliary stenting after complete clearance of common bile duct stones in patients awaiting cholecystectomy remains controversial. This randomized controlled trial investigates whether temporary plastic biliary stent placement after documented complete choledocholithiasis clearance reduces the recurrence of choledocholithiasis and biliary complications in patients awaiting cholecystectomy for concomitant cholelithiasis.
Between March 2024 and September 2025, 200 patients with concomitant cholelithiasis and choledocholithiasis were randomized to either prophylactic biliary stenting (n=100) or no stenting (n=100) after complete stone clearance documented on occlusion cholangiogram during endoscopic retrograde cholangiopancreatography (ERCP).
The primary outcome was symptomatic choledocholithiasis recurrence within 3 months. Secondary outcomes included biliary complications (cholangitis, cholecystitis, post-ERCP pancreatitis, bleeding), radiation exposure metrics, and cost-effectiveness.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18 to 75 years at the time of enrollment
✓. Diagnosis of concomitant cholelithiasis and choledocholithiasis
✓. Successful ERCP with complete choledocholithiasis clearance documented on occlusion cholangiogram during the index procedure
✓. Endoscopic sphincterotomy (EST) performed during ERCP
✓. Ability to provide informed consent
✓. Scheduled for laparoscopic cholecystectomy within 2-4 weeks of ERCP
✓. No contraindications to cholecystectomy
Exclusion criteria
✕. Incomplete choledocholithiasis clearance (residual stones on occlusion cholangiogram)