ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly (NCT07001423) | Clinical Trial Compass
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.
1This trial is comparing cholecystectomy against not doing surgery after a successful bile duct stone removal in elderly patients — given my age and overall health, which approach does my doctor currently lean toward for me, and why?
2The trial's main outcome tracks death, major complications, and recurrent biliary events — what specific risks from either having or skipping the gallbladder removal surgery am I most likely to face based on my personal health history?
3Since this trial is labeled 'Phase NA,' meaning it's comparing two established management strategies rather than testing a brand-new treatment, how does that affect what my doctor already knows about the safety of each option, and is standard care outside the trial a reasonable path for me?
4If I were to join this trial, would I have any say in whether I receive surgery or watchful waiting, or would that be randomly assigned — and how would my doctor manage my care if I had a recurrent biliary event during the study?
5Are there specific factors about my age, other medical conditions, or how the bile duct stone removal went that would make me a better candidate for one arm of this trial over the other, or that might mean I should consider a different approach altogether?
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
1
Number of participants with composite outcome of death, major complication or recurrent biliary event