Clinical Trial

CBD Stenting vs Non-Stenting for Choledocholithiasis

Completed
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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.
Trial Details
NCT Number NCT07331142
Lead Sponsor National Liver Institute, Egypt
Conditions Choledocholithiasis
Enrollment 200 participants
Start Date 2024-03-01
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-09