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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Laparoscopic cholecystectomy
Procedure/SurgeryLaparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: CholecystectomyActive comparator 1 intervention
Group B: Wait-and-seeNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants with composite outcome of death, major complication or recurrent biliary event
The primary outcome is a composite outcome including death within 1 year after randomization, the occurrence of major complications within 30 days from surgery and recurrent biliary event requiring hospitalization. within 1 year after randomization. A recurrent biliary event refers to cholecystitis, pancreatitis, cholangitis, or bile duct stones. Major complications were defined as infectious, cardiovascular and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher)
Time frame
From randomization to 1 yearSecondary outcomes
1
Number of good days
Number of days alive and out of hospital
Time frame
From randomization to 1 year2
EQ VAS value
Quality of life is measured using EuroQOL EQ-5D-5L instrument, EQ VAS values are compared. 0 represents the worst health a person can imagine and 100 represents the the best health a person can imagine. EQ-5D-5L dimension responses are reported as a descriptive data
Time frame
at 30 days, 180 days and 365 days after randomization3
Survival
Survival is measured using Kaplan-Meier analysis
Time frame
From randomization to 1 year4
Number of patients with major complications
Number of patients with major complications defined as infectious, cardiovascular, and pulmonary complications, and surgical complication (Clavien-Dindo grade III or higher)
Time frame
From randomization to 1 yearSponsors and contacts
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Source ClinicalTrials.gov