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?

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).

Study Overview

• Status: Completed
• Conditions: Children; Cholecystolithiasis; Choledocholithiasis; Common Bile Duct Calculi; Cholangiopancreatography, Endoscopic Retrograde; Laparoscopic Cholecystectomy in Children
• Intervention / Treatment: Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy; Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

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).

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Russian Federation
  • Московская область
    • Moscow, Московская область, Russian Federation, 142636
      • Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children under 18 years of age diagnosed with cholecystocholedocholithiasis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ERCP, EST and LC in one 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 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.
ERCP, EST and LC on rehospitalization	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding		30 days after ERCP
Perforation	by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)	30 days after ERCP
Bile leak	bile aspirated from the abdominal cavity	30 days after ERCP
Acute cholangitis	intermittent chills, fever, increased proinflammatory blood markers after ERCP	60 days after ERCP
Bile duct stricture	after ERCP	1 year after ERCP
Time spent in hospital until discharge		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	1 month
Acute pancreatitis	at least two out of three criteria according to the classification developed by the INSPPIRE group	30 days after ERCP
Duration of the laparoscopic cholecystectomy,min		From enrollment to the end of treatment (3 month)
Duration of the Endoscopic retrograde cholangiopancreatography,min		From enrollment to the end of treatment (3 month)

Collaborators and Investigators

• Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
• Investigators: Study Director: Dmitriy А Pyhteev, PhD, Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky; Principal Investigator: Leonid M Elin, Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Actual): February 4, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Children; Endoscopic retrograde cholangiopancreatography (ERCP); Common Bile Duct Calculi; Сholedocholelysis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Gallbladder Diseases; Common Bile Duct Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Other Study ID Numbers: 16/30.10.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A complete dataset can be provided upon reasoned request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No