Trials / Completed

CompletedNCT06672991

ERCP and LC for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?

Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?

Status: Completed
Phase: —
Study type: Observational
Enrollment: 25 (actual)

Sponsor: Moscow Regional Research and Clinical Institute (MONIKI) · Other Government
Sex: All
Age: 0 Years – 18 Years
Healthy volunteers: Not accepted

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).

Detailed description

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).

Conditions

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 on a delayed basis, 7 to 15 days after ERCP in a single hospitalization
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 for readmission, 1 month after ERCP under general anesthesia.

Timeline

Start date: 2024-11-21
Primary completion: 2025-02-04
Completion: 2025-02-05
First posted: 2024-11-04
Last updated: 2025-02-07

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT06672991. Inclusion in this directory is not an endorsement.