IDUS in CBD Stone Recurrence High Risk Patients (NCT06265311) | Clinical Trial Compass
CompletedNot Applicable
IDUS in CBD Stone Recurrence High Risk Patients
China248 participantsStarted 2021-11-02
Plain-language summary
This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
Who can participate
Age range
18 Years – 80 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:
* 1.Clinical diagnosis of common bile duct stones 2.At least one of the following, diameter of CBD\>1.5cm, or number of calculi\>2, or lithotripsy during ercp
Exclusion Criteria:
* 1\. Clinical diagnosis of liver or biliary malignant tumor. 2. Clinical diagnosis of duodenal malignant tumor 3. Failure or unexpected termination of ERCP 4. Surgery history of gallbladder or bile duct.
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
recurrence of bile duct stone or cholangitis
Timeframe: 48 weeks
2
need for a nasobiliary tube
Timeframe: 2 weeks
3
need for stents
Timeframe: 4 weeks
Trial details
NCT IDNCT06265311
SponsorShanghai Municipal Hospital of Traditional Chinese Medicine