Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duc… (NCT05638789) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal
Malaysia66 participantsStarted 2021-06-28
Plain-language summary
Gallstone is a worldwide clinical problem which affecting most of the populations with incidence of 15 to 20% in west and 10% in Asians. About 5 to 15% of patient with gallstone will go on to develop bile duct calculi. There are several endoscopic strategies developed for treatment of common bile duct stone such as endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilatation (EPLBD) and combination of EST plus EPLBD. Our aim of this study is to compare efficacy, and safety of EST alone group versus EST plus EPLBD group in removing CBD stone.
Who can participate
Age range
18 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
. Patient's age 18 and above
. Patient with CBD stone documented on imaging studies
Exclusion criteria
. CBD stone size more than 15mm
. CBD stone number more than 3
. Concurrent hepatobiliary tumour
. Intrahepatic stone
. Bleeding tendencies: coagulopathy, thrombocytopenia, patient on anticoagulant medication
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
1
Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD
Timeframe: 12 months
2
Complication rate of EST alone versus EST plus EPLBD in removing CBD stone