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

NCT ID: NCT06676241

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2025-03-05

Brief Summary

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.

Detailed Description

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.

Conditions

Choledocholithiasis; Cholecystolithiasis; Cholangiopancreatography, Endoscopic Retrograde; Laparoscopic Cholecystectomy; Children; Acute Pancreatitis (AP); Common Bile Duct Calculi

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ERCP, EST and simultaneous LC

Patients aged 10-80 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed immediately after ERCP with ES under general anesthesia

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 immediately after ERCP with ES under general anesthesia.

ERCP, EST and LC in a delayed manner

Patients aged 0-17 years initially underwent ERCP with ES by an endoscopist with the consent of the patient or legal representative. Patients underwent endoscopic procedures using fluoroscopy in the operating room, under general anesthesia. Laparoscopic cholecystectomy was performed in a delayed manner, not earlier than 7 days after ERCP

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 no earlier than 7 days after ERCP

Interventions

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 immediately after ERCP with ES under general anesthesia.

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 no earlier than 7 days after ERCP

Intervention Type: PROCEDURE

Other Intervention Names

Cholangiopancreatography; Laparoscopic; Cholangiopancreatography; Laparoscopic

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moscow Regional Research and Clinical Institute (MONIKI)

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dmitriy А Pyhteev, PhD

Role: STUDY_DIRECTOR

Head of the Department of Pediatric Surgery

Leonid M Elin

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Moscow, Moscow Oblast, Russia

Countries

Russia

Other Identifiers

16/17.10.2024

Identifier Type: -

Identifier Source: org_study_id