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CBD Stenting vs Non-Stenting for Choledocholithiasis

NCT07331142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Choledocholithiasis

Interventions

PROCEDURE

Temporary Plastic Biliary Stent Placement

Endoscopic placement of a temporary plastic biliary stent (7-10 French gauge) across the sphincter of Oddi after documented complete choledocholithiasis clearance on occlusion cholangiogram during ERCP. The stent maintains bile duct patency and is left in place until cholecystectomy.

PROCEDURE

Endoscopic Retrograde Cholangiopancreatography with Stone Clearance

Standard endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy and complete choledocholithiasis clearance documented on occlusion cholangiogram. No temporary biliary stent is placed.

Sponsors & Collaborators

  • National Liver Institute, Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-08-01
Completion
2025-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07331142 on ClinicalTrials.gov