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Completed

NCT Number: NCT06676241

One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis

In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.

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Key information

About this study

Nowadays there is no gold standard for the treatment of choledocholithiasis combined with cholecystolithiasis in the pediatric population. The most common method for resolving the biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). In the adult practice, the approaches to the treatment of choledocholithiasis include the following items: 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, a great number of medical institutions do not have an opportunity to use these methods due to the difficulties of implementation and the need for special training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis also remains a subject of debate. Numerous studies recommend early LC after ERCP. However, there are high risks of injury to the common bile duct and hepatic vessels against the background of acute inflammatory process in the area of hepatoduodenal ligament. In this study, it is planned to compare ERCP with ES + delayed LC in children, with one-stage LC + ERCP with ES in adults to confirm that ERCP with ES + delayed LC is more suitable for pediatric patients with cholecystocholedocholithiasis.

The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with delayed laparoscopic cholecystectomy in children with cholecystocholedocholithiasis compared with one-stage cholangiopancreatography, endoscopic sphincterotomy and laparoscopic cholecystectomy in adults with cholecystocholedocholithiasis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent from the patient, child or legal representative
  • Age 0-80 years
  • Acute cholecystitis
  • Choledocholithiasis
  • Intraoperative ERCP
  • Preoperative ERCP followed by cholecystectomy

Exclusion criteria

  • Unwillingness or inability to consent to the study
  • Pregnancy
  • Age > 80 years
  • Previous ERCP or percutaneous transhepatic biliary drainage
  • Anastomosis in the upper gastrointestinal tract
  • Benign or malignant stricture
  • Preoperative comorbidities: gastrointestinal bleeding, severe liver disease, acute and chronic cholangitis, other known cholestatic hepatopancreatobiliary disease, septic shock.
  • In combination with Mirizzi syndrome and intrahepatic bile duct stones
  • Congenital anomaly of the biliary tract
  • Malignant neoplasms
  • Acute pancreatitis

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 immediately after ERCP with ES under general anesthesia.

Other names: Cholangiopancreatography, Laparoscopic

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 patient underwent the endoscopic procedure using fluoroscopy in the operating room, under general anesthesia. Subsequently, laparoscopic cholecystectomy was performed on a delayed basis no earlier than 7 days after ERCP

Other names: Cholangiopancreatography, Laparoscopic

Primary outcomes

  1. Recurrence of stones in the common bile duct

    Time frame: 30 days after ERCP

    The diagnosis of the stone in the common bile duct.

Secondary outcomes

  1. Bleeding

    Time frame: 30 days after ERCP

    decreased hemoglobin level, visual picture during endoscopic examination, positive stool for occult blood

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

    Time frame: 1 month

  8. Duration of the laparoscopic cholecystectomy,min

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

  9. Acute pancreatitis

    Time frame: within 14 days after ERCP

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

  10. Duration of the Endoscopic retrograde cholangiopancreatography

    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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
Mar 10, 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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