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

NCT06672991 | Completed

• 1 other identifier: 16/30.10.2024
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Choledocholithiasis; Cholecystolithiasis; Cholangiopancreatography, Endoscopic Retrograde; Laparoscopic Cholecystectomy in Children; Children; Common Bile Duct Calculi

Keywords

Children; Endoscopic retrograde cholangiopancreatography (ERCP); Сholedocholelysis; Common Bile Duct Calculi

Outcome Measures

Primary Outcomes (1)

• 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.

  60 days after ERCP

Secondary Outcomes (10)

• Bleeding

  30 days after ERCP

• Perforation

  30 days after ERCP

• Bile leak

  30 days after ERCP

• Acute cholangitis

  60 days after ERCP

• Bile duct stricture

  1 year after ERCP

Study Arms (2)

ERCP, EST and LC in one hospitalization

Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

ERCP, EST and LC on rehospitalization

Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

Interventions

Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy PROCEDURE

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

ERCP, EST and LC in one hospitalization

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children under 18 years of age diagnosed with cholecystocholedocholithiasis

You may qualify if:

• Informed consent from child or legal guardian
• Age 0-18 years
• Acute cholecystitis
• Choledocholithiasis

You may not qualify if:

• 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

Sponsors & Collaborators

• Moscow Regional Research and Clinical Institute (MONIKI): lead

Study Sites (1)

Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Moscow, Moscow Oblast, 142636, Russia

Location

MeSH Terms

Conditions

Choledocholithiasis; Cholecystolithiasis; Gallstones

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dmitriy А Pyhteev, PhD

  Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

  STUDY DIRECTOR

• Leonid M Elin

  Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: November 21, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 5, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)