Status:
RECRUITING
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Cholecystectomy, Laparoscopic
Choledocholithiasis
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint...
Detailed Description
Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-an...
Eligibility Criteria
Inclusion
- Common bile duct stones cleared after Endoscopic Retrograde Cholangio Pancreatography (ERCP)
- Age \>= 80 years or age 75-79 years with a Charlson Comorbidity index \>=2
- gallbladder in situ
Exclusion
- Acute Cholecystitis
- Biliary Pancreatitis
- Severe or moderately severe post-ERCP pancreatitis
- Chronic pancreatitis
- Bile duct pathology
- Widespread malignancy
- Unable to give consent
Key Trial Info
Start Date :
October 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2032
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07001423
Start Date
October 3 2025
End Date
August 31 2032
Last Update
October 7 2025
Active Locations (12)
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1
Helsinki University Hospital, Jorvi
Espoo, Finland
2
Kanta-Häme Central Hospital
Hämeenlinna, Finland
3
Helsinki University Hospital, Meilahti
Helsinki, Finland
4
Pohjois-Karjala Central Hospital
Joensuu, Finland