*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*

Not Applicable

Not yet recruiting

• Conditions: Calcular Obstructive Jaundice

• Registration Number: NCT07084493
• Lead Sponsor: Assiut University

Brief Summary

Primary objective:

Compare recurrence rates of CBD stones in stented versus non-stented patients.

Secondary objectives:

Identify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Explore impact on quality of life and ease of subsequent cholecystectomy.

Detailed Description

Choledocholithiasis, the presence of stones in the common bile duct (CBD), occurs in 10-20% of patients with symptomatic gallstones and can lead to severe complications such as obstructive jaundice, cholangitis, and pancreatitis Endoscopic retrograde cholangiopancreatography (\*\*ERCP\*\*) with stone extraction is the gold standard treatment, achieving \>90% success rates in ductal clearance.

Despite successful initial clearance, CBD stone recurrence remains a significant issue, with reported rates ranging from 4% to 24% .

To reduce recurrence, prophylactic biliary stenting has been proposed, particularly in high-risk patients (e.g., large or multiple stones, dilated CBD, periampullary diverticulum) However, its routine use remains controversial due to conflicting evidence on efficacy, stent-related complications (e.g., migration, occlusion, cholangitis), and increased healthcare costs.

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-15
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-09
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.	3 months	Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt