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ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Study acronym: COFFEE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Start date changed from estimate of Oct 3, 2025 to Oct 9, 2025 Show 4 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study description revised
    • Publications: details revised at 4 of 4 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 1, 2025 to Oct 3, 2025
    • Site details revised at 12 of 12 sites
    v3
  3. Minor Secondary endpoints: details revised at 2 of 8 entries
    • Eligibility criteria expanded, about 4 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07001423
Lead Sponsor Helsinki University Central Hospital
Conditions
(from sponsor)
Cholecystectomy, Laparoscopic, Choledocholithiasis, Cholelithiasis
Related terms Choledocholithiasis, Cholelithiasis
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov