Clinical Trial

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Study acronym: COFFEE
Recruiting
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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 is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-05-23; most recent amendment 2025-10-02.
Status change: Not Yet Recruiting → Recruiting 2025-10-02
Trial Details
NCT Number NCT07001423
Lead Sponsor Helsinki University Central Hospital
Conditions Cholecystectomy, Laparoscopic, Choledocholithiasis, Cholelithiasis
Enrollment 400 participants
Start Date 2025-10-03
Primary Completion 2031-08-31 (estimated)
Study Completion 2032-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-07