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Completed

NCT Number: NCT06672991

ERCP and LC 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).

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Key information

Conditions

Choledocholithiasis Bile Duct Diseases Biliary Tract Diseases Calculi Children Cholangiopancreatography, Endoscopic Retrograde Cholecystolithiasis Cholelithiasis Common Bile Duct Calculi Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases Gallstones Laparoscopic Cholecystectomy in Children Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, Moscow Oblast, 142636, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Recurrence of common bile duct stones

    Time frame: 60 days after ERCP

    The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound, if confirmed, before performing laparoscopic cholecystectomy.

Secondary outcomes

  1. Bleeding

    Time frame: 30 days after ERCP

  2. Perforation

    Time frame: 30 days after ERCP

    by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)

  3. Bile leak

    Time frame: 30 days after ERCP

    bile aspirated from the abdominal cavity

  4. Acute cholangitis

    Time frame: 60 days after ERCP

    intermittent chills, fever, increased proinflammatory blood markers after ERCP

  5. Bile duct stricture

    Time frame: 1 year after ERCP

    after ERCP

  6. Time spent in hospital until discharge

    Time frame: from admission to hospital until the end of treatment (up to 8 weeks)

  7. Technical success

    Time frame: 1 month

    • success of the procedures as documented by a yes or no

  8. Acute pancreatitis

    Time frame: 30 days after ERCP

    at least two out of three criteria according to the classification developed by the INSPPIRE group

  9. Duration of the laparoscopic cholecystectomy,min

    Time frame: From enrollment to the end of treatment (3 month)

  10. Duration of the Endoscopic retrograde cholangiopancreatography,min

    Time frame: From enrollment to the end of treatment (3 month)

Sponsors and collaborators

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI)

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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