Status:
COMPLETED
Immediate vs. Elective Endoscopic Removal of Large CBD Stones in High-Risk Elderly Patients
Lead Sponsor:
National Liver Institute, Egypt
Conditions:
Choledocholithiasis
Jaundice, Obstructive
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare two different approaches for removing large or multiple stones from the common bile duct in older adults with chronic diseases. The main questions it aims...
Detailed Description
This study was designed to evaluate two different endoscopic treatment strategies for managing large or multiple common bile duct (CBD) stones in elderly patients considered high-risk due to age and c...
Eligibility Criteria
Inclusion
- Age ≥ 65 years
- Charlson Comorbidity Index (CCI) ≥ 3
- Presence of large or multiple CBD stones (defined as ≥1 stone ≥15 mm or ≥3 stones each ≥10 mm on imaging)
- Ability to provide informed consent (or via legal representative).
Exclusion
- Contraindications to ERCP or general anesthesia
- History of biliary surgery or altered anatomy
- Benign or malignant strictures of the distal CBD
- Intrahepatic bile duct stones
- Moderate to severe cholangitis
- Malignancy or serious condition with life expectancy \<6 months
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06948279
Start Date
February 1 2022
End Date
September 1 2024
Last Update
May 6 2025
Active Locations (1)
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1
National Liver Institute, Menoufia University, Egypt.
Shebeen El-Kom, Monufia Governorate, Egypt, 32511