NCT06676241

One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 44 (actual)
• Sponsor: Moscow Regional Research and Clinical Institute (MONIKI) · Other Government
• Sex: All
• Age: 0 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Choledocholithiasis
• Cholecystolithiasis
• Cholangiopancreatography, Endoscopic Retrograde
• Laparoscopic Cholecystectomy
• Children
• Acute Pancreatitis (AP)
• Common Bile Duct Calculi

Interventions

Type	Name	Description
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.
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 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

Timeline

• Start date: 2024-11-13
• Primary completion: 2025-02-20
• Completion: 2025-03-05
• First posted: 2024-11-06
• Last updated: 2025-03-10

Locations

1 site across 1 country: Russia