ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorHelsinki University Central Hospital
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 groupsSponsors and collaborators
Source ClinicalTrials.gov