RecruitingNot Applicable

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

Finland400 participantsStarted 2025-10-03

Plain-language 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.

Who can participate

Age range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Acute Cholecystitis * Biliary Pancreatitis * Severe or moderately severe post-ERCP pancreatitis * Chronic pancreatitis * Bile duct pathology * Widespread malignancy * Unable to give consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with composite outcome of death, major complication or recurrent biliary event

Timeframe: From randomization to 1 year

Trial details

NCT IDNCT07001423

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-08-31

Contact for this trial

Panu Mentula, MD, PhD

+358504270183 panu.mentula@hus.fi

View on ClinicalTrials.gov More Cholecystectomy, Laparoscopic trials