An observational study in Choledocholithiasis, Cholecystolithiasis and Cholangiopancreatography, Endoscopic Retrograde, sponsored by Moscow Regional Research and Clinical Institute (MONIKI). Completed at 1 site in Russian Federation. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Moscow Regional Research and Clinical Institute (MONIKI) · Observational
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).
There is no gold standard for the treatment of cholecystocholedocholithiasis in the pediatric population. The most common method for resolving biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). There are different approaches to the treatment of cholecystocholedocholithiasis: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and LC after ERCP. Both LCBDE and LERV allow for the simultaneous treatment of cholecystocholedocholithiasis. However, many medical institutions do not have the opportunity to use these methods due to the difficulties of implementation and the need for specialized training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis remains a subject of debate. The present study aims to compare ERCP with ES + delayed LC in intra- and re-hospitalization in pediatric patients with cholecystocholedocholithiasis.
The aim of this 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).
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 25 is below the median of 200 across 31 observational studies indexed under Choledocholithiasis.
Browse Choledocholithiasis studies →Moscow Regional Research and Clinical Institute (MONIKI) is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
children under 18 years of age diagnosed with cholecystocholedocholithiasis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy
Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy
Initially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed on a delayed basis, 7 to 15 days after ERCP in a single hospitalization
Initially, ERCP with EST was performed by an endoscopist with the consent of the patient or legal representative. The patient underwent the endoscopic procedure using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed on a delayed basis for readmission, 1 month after ERCP under general anesthesia.
Recurrence of common bile duct stones
The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound, if confirmed, before performing laparoscopic cholecystectomy.
Time frame: 60 days after ERCP
Bleeding
Time frame: 30 days after ERCP
Perforation
by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)
Time frame: 30 days after ERCP
Bile leak
bile aspirated from the abdominal cavity
Time frame: 30 days after ERCP
Acute cholangitis
intermittent chills, fever, increased proinflammatory blood markers after ERCP
Time frame: 60 days after ERCP
Bile duct stricture
after ERCP
Time frame: 1 year after ERCP
Time spent in hospital until discharge
Time frame: from admission to hospital until the end of treatment (up to 8 weeks)
Technical success
- success of the procedures as documented by a yes or no
Time frame: 1 month
Acute pancreatitis
at least two out of three criteria according to the classification developed by the INSPPIRE group
Time frame: 30 days after ERCP
Duration of the laparoscopic cholecystectomy,min
Time frame: From enrollment to the end of treatment (3 month)
Duration of the Endoscopic retrograde cholangiopancreatography,min
Time frame: From enrollment to the end of treatment (3 month)
Plan to share: Yes — A complete dataset can be provided upon reasoned request
No publications or documents are linked to this record.
Ran from Nov 2024 to primary completion in Feb 2025, 2 months.
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Moscow Regional Research and Clinical Institute (MONIKI)