ERCP and LC for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Re… (NCT06672991) | Clinical Trial Compass
CompletedNot Applicable
ERCP and LC for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?
Russia25 participantsStarted 2024-11-21
Plain-language summary
Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC after ERCP. Given the inflammation of the gallbladder and the inflammatory process in the hepatoduodenal ligament, early laparoscopic cholecystectomy can lead to various intraoperative complications. The aim of this retrospective study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with laparoscopic cholecystectomy in a delayed manner (single or repeated hospitalization).
Who can participate
Age range
0 Years – 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:
* Informed consent from child or legal guardian
* Age 0-18 years
* Acute cholecystitis
* Choledocholithiasis
Exclusion Criteria:
* Unwillingness or inability to consent to the study
* Previous ERCP or percutaneous transhepatic biliary drainage
* Benign or malignant stricture
* Preoperative comorbidities: gastrointestinal bleeding, severe liver disease, acute and chronic cholangitis, septic shock.
* In combination with Mirizzi syndrome and intrahepatic bile duct stones
* Congenital anomaly of the biliary tract
* Malignant neoplasms
* Acute pancreatitis before the procedure
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.
1This trial looked at whether it's better for children with stones in both the gallbladder and the bile duct to have the ERCP and the laparoscopic gallbladder removal done in one hospital stay versus two separate ones — based on what this study found, which approach would you recommend for my child and why?
2Since this trial specifically measured whether bile duct stones came back after treatment, what did it find about recurrence rates, and how does that affect the timing of my child's procedures?
3This study is now completed — are the results published yet, and can you share what they showed about the safety and outcomes of combining these two procedures in children?
4Given that this trial was designed specifically for children, how does my child's age and size factor into which surgical approach you'd recommend for managing both their gallstones and bile duct stones?
5Would you consider standard care for my child's condition to be what this trial was testing, or are there other treatment options we should weigh before deciding on a plan??
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 common bile duct stones
Timeframe: 60 days after ERCP
Trial details
NCT IDNCT06672991
SponsorMoscow Regional Research and Clinical Institute (MONIKI)