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

M

Moscow Regional Research and Clinical Institute (MONIKI)

Status

Completed

Conditions

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

Treatments

Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

Study type

Observational

Funder types

Other

Identifiers

NCT06672991
16/30.10.2024

Details and patient eligibility

About

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).

Full 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).

Enrollment

25 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

25 participants in 2 patient groups

ERCP, EST and LC in one hospitalization
Treatment:
Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy
Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy
ERCP, EST and LC on rehospitalization
Treatment:
Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy
Procedure: Endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

Trial contacts and locations

1

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Central trial contact

Leonid M Elin

Data sourced from clinicaltrials.gov

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