Immediate vs. Elective Endoscopic Removal of Large CBD Stones in High-Risk Elderly Patients (NCT06948279) | Clinical Trial Compass
CompletedNot Applicable
Immediate vs. Elective Endoscopic Removal of Large CBD Stones in High-Risk Elderly Patients
Egypt400 participantsStarted 2022-02-01
Plain-language summary
The goal of this clinical trial is to compare two different approaches for removing large or multiple stones from the common bile duct in older adults with chronic diseases. The main questions it aims to answer are:
Is it better to remove the stones immediately during the first endoscopic procedure? Or is it safer and more effective to place a temporary plastic stent first and remove the stones later?
Researchers will compare these two approaches to see which one leads to better stone clearance and fewer complications.
Participants will:
Undergo an endoscopic procedure (ERCP) to treat their bile duct stones. Be randomly assigned to either have immediate stone removal or have a stent placed first, with stone removal scheduled 8-12 weeks later.
Attend follow-up visits to monitor their recovery and check for complications.
This study is being conducted at the National Liver Institute, Menoufia University, Egypt.
Who can participate
Age range
65 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:
* Age ≥ 65 years
* Charlson Comorbidity Index (CCI) ≥ 3
* Presence of large or multiple CBD stones (defined as ≥1 stone ≥15 mm or ≥3 stones each ≥10 mm on imaging)
* Ability to provide informed consent (or via legal representative).
Exclusion Criteria:
* Contraindications to ERCP or general anesthesia
* History of biliary surgery or altered anatomy
* Benign or malignant strictures of the distal CBD
* Intrahepatic bile duct stones
* Moderate to severe cholangitis
* Malignancy or serious condition with life expectancy \<6 months
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.