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RECRUITING Not applicable ClinicalTrials.gov

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Sponsor: Helsinki University Central Hospital • ClinicalTrials.gov ID: NCT07001423

Registry updated: 2026-09-16
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Description

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.

Interventions

  • Laparoscopic cholecystectomy (Procedure)
    Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * Acute Cholecystitis * Biliary Pancreatitis * Severe or moderately severe post-ERCP pancreatitis * Chronic pancreatitis * Bile duct pathology * Widespread malignancy * Unable to give consent

Conditions

Cholecystectomy, Laparoscopic Choledocholithiasis Cholelithiasis

Locations

  • Helsinki University Hospital, Jorvi — Espoo, Finland
  • Kanta-Häme Central Hospital — Hämeenlinna, Finland
  • Helsinki University Hospital, Meilahti — Helsinki, Finland
  • Pohjois-Karjala Central Hospital — Joensuu, Finland
  • Keski-Suomi Central Hospital — Jyväskylä, Finland
  • Kymenlaakso Central Hospital — Kotka, Finland
  • Kuopio University Hospital — Kuopio, Finland
  • Päijät-Häme Central Hospital — Lahti, Finland
  • Oulu University Hospital — Oulu, Finland
  • Tampere University Hospital — Tampere, Finland
  • Turku University Hospital — Turku, Finland
  • Vaasa Central Hospital — Vaasa, Finland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record