NCT07084493

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

*Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Calcular Obstructive Jaundice

Interventions

Type	Name	Description
DEVICE	CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent	prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent
DEVICE	biliary stent	prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-07-24
• Last updated: 2025-08-07

Locations

1 site across 1 country: Egypt