Health Trials

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Acute Cholecystitis

Biliary Pancreatitis

Severe or moderately severe post-ERCP pancreatitis

Chronic pancreatitis

Trial design

Treatments tested in this trial

  • Laparoscopic cholecystectomy

Treatment groups

400 Participants
are divided into 2 treatment groups

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

Sponsors and collaborators

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov