The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis (NCT03754491) | Clinical Trial Compass
CompletedNot Applicable
The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis
Taiwan196 participantsStarted 2018-10-01
Plain-language summary
In expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for stone removal later. However, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. Investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.
Who can participate
Age range
18 Years – 90 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:
* naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis.
Exclusion Criteria:
* procedural failure requiring an anatomy-modifying procedure, such as a Billroth II subtotal gastrectomy or R-en-Y gastrojejunostomy ;
* stenosis of the pyloric ring ;
* tumor-related obstruction;
* failure to locate the papilla ;
* active peptic ulcer bleeding ;
* intolerance due to inadequate sedation
* CBD sludge;
* non-naïve papilla in ERCP
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
Post ERCP pancreatitis
Timeframe: After ERCP, an average of 7 days
2
Bowel perforation
Timeframe: After ERCP, an average of 7 days
3
Papillary bleeding
Timeframe: After ERCP, an average of 7 days
4
Success rate of stone removal
Timeframe: an average of 14 days.
5
Cost of hospitalization
Timeframe: From emergent department to the timing of being discharged, and an average of 30 days