One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreato… (NCT06676241) | Clinical Trial Compass
CompletedNot Applicable
One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis
Russia44 participantsStarted 2024-11-13
Plain-language summary
In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.
Who can participate
Age range
0 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:
* Informed consent from the patient, child or legal representative
* Age 0-80 years
* Acute cholecystitis
* Choledocholithiasis
* Intraoperative ERCP
* Preoperative ERCP followed by cholecystectomy
Exclusion Criteria:
* Unwillingness or inability to consent to the study
* Pregnancy
* Age \> 80 years
* Previous ERCP or percutaneous transhepatic biliary drainage
* Anastomosis in the upper gastrointestinal tract
* Benign or malignant stricture
* Preoperative comorbidities: gastrointestinal bleeding, severe liver disease, acute and chronic cholangitis, other known cholestatic hepatopancreatobiliary disease, septic shock.
* In combination with Mirizzi syndrome and intrahepatic bile duct stones
* Congenital anomaly of the biliary tract
* Malignant neoplasms
* Acute pancreatitis
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 stones in the common bile duct
Timeframe: 30 days after ERCP
Trial details
NCT IDNCT06676241
SponsorMoscow Regional Research and Clinical Institute (MONIKI)