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 80 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Moscow Regional Research and Clinical Institute (MONIKI) · Observational
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.
Nowadays there is no gold standard for the treatment of choledocholithiasis combined with cholecystolithiasis in the pediatric population. The most common method for resolving the biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). In the adult practice, the approaches to the treatment of choledocholithiasis include the following items: 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, a great number of medical institutions do not have an opportunity to use these methods due to the difficulties of implementation and the need for special training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis also remains a subject of debate. Numerous studies recommend early LC after ERCP. However, there are high risks of injury to the common bile duct and hepatic vessels against the background of acute inflammatory process in the area of hepatoduodenal ligament. 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.
The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with delayed laparoscopic cholecystectomy in children with cholecystocholedocholithiasis compared with one-stage cholangiopancreatography, endoscopic sphincterotomy and laparoscopic cholecystectomy in adults with cholecystocholedocholithiasis.
109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.
This study's enrollment of 44 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.
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Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
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.
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.
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.
Patients aged 10-80 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia
Procedure: endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy
Patients aged 0-17 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed in a delayed manner, not earlier than 7 days after ERCP
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 immediately after ERCP with ES under general anesthesia.
Also known as: Cholangiopancreatography, Laparoscopic
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 no earlier than 7 days after ERCP
Also known as: Cholangiopancreatography, Laparoscopic
Recurrence of stones in the common bile duct
The diagnosis of the stone in the common bile duct.
Time frame: 30 days after ERCP
Bleeding
decreased hemoglobin level, visual picture during endoscopic examination, positive stool for occult blood
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
Duration of the laparoscopic cholecystectomy,min
Time frame: From enrollment to the end of treatment (3 month)
Acute pancreatitis
at least two out of three criteria according to the classification developed by the INSPPIRE group
Time frame: within 14 days after ERCP
Duration of the Endoscopic retrograde cholangiopancreatography
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, 3 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Moscow Regional Research and Clinical Institute (MONIKI)