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RecruitingNot ApplicableNCT07001423

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Sponsor

Helsinki University Central Hospital

Enrollment

400 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

CholedocholithiasisCholelithiasisCholecystectomy, Laparoscopic

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.

Eligibility

Min Age: 75 Years

Inclusion Criteria3

  • 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 Criteria7

  • Acute Cholecystitis
  • Biliary Pancreatitis
  • Severe or moderately severe post-ERCP pancreatitis
  • Chronic pancreatitis
  • Bile duct pathology
  • Widespread malignancy
  • Unable to give consent
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Interventions

PROCEDURELaparoscopic cholecystectomy

Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone

Locations(12)

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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NCT07001423

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