An interventional study of Laparoscopic cholecystectomy in Cholecystectomy, Laparoscopic, Choledocholithiasis and Cholelithiasis, sponsored by Helsinki University Central Hospital. Recruiting at 12 sites in Finland. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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.
Elderly patients with common bile duct stones are asked to participate this randomized trial after successful endoscopic removal of common bile duct stones. The hypothesis of the study is that wait-and-see policy is non-inferior to laparoscopic cholecystectomy. Four hundred patients are randomized 1:1 to either laparoscopic cholecystectomy group or wait-and see group. Cholecystectomy is done on the same admission or within two weeks after randomization. One interim analysis is planned for the trial after 100 randomized patients to assess safety. The trial is terminated if there is a statistically significant difference in primary outcome with p\<0.001 (chi-square test) between the study arms.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 76 interventional studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Laparoscopic cholecystectomy is done within 2 weeks after endoscopic removal of common bile duct stones.
Procedure: Laparoscopic cholecystectomy
After endoscopic removal of common bile duct stones, patients are managed non-operatively. During the follow-up cholecystectomy will be available on demand.
Laparoscopic cholecystectomy within 2 weeks after endoscopic removal of common bile duct stone
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 year
Number of good days
Number of days alive and out of hospital
Time frame: From randomization to 1 year
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 randomization
Survival
Survival is measured using Kaplan-Meier analysis
Time frame: From randomization to 1 year
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 year
Number of patients with recurrent biliary event
Number of patients with recurrent biliary event (cholecystitis, pancreatitis, cholangitis, or symptomatic bile duct stones)
Time frame: From randomization to 1 year
Composite outcome of death or occurrence of major complications or recurrent biliary event requiring hospitalization
The same as primary outcome, but after 2 years follow-up
Time frame: From randomization to 2 years
Number of patients with uncomplicated biliary pain or post cholecystectomy pain
Uncomplicated biliary pain/ post cholecystectomy pain. Specific 5 criteria of biliary pain include : 1. severe pain attacks, 2. lasting 15 to 30 minutes or longer, 3. location in epigastrium or right upper quadrant, 4. pain radiating to the back, 5. a positive pain response to simple analgesics
Time frame: At 30, 180 and 365 days after randomization
Healthcare costs
Healthcare costs related to bile stones; including laboratory tests, imaging (ultra sound, computer tomography, magnetic resonance imaging), procedures (Endoscopic Retrograde Cholangio Pancreatography (ERCP), laparoscopic cholecystectomy), emergency visits and hospital days.
Time frame: From randomization to 1 year
Plan to share: No
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