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

NCT ID: NCT06672991

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-21

Study Completion Date

2025-02-05

Brief Summary

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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

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ERCP, EST and LC in one hospitalization

Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

Intervention Type 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 on rehospitalization

Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moscow Regional Research and Clinical Institute (MONIKI)

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dmitriy А Pyhteev, PhD

Role: STUDY_DIRECTOR

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

Leonid M Elin

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Moscow, Moscow Oblast, Russia

Site Status

Countries

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Russia

Other Identifiers

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16/30.10.2024

Identifier Type: -

Identifier Source: org_study_id

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