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

NCT06676241 | Completed

• 1 other identifier: 16/17.10.2024
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Сholedocholelysis; Endoscopic retrograde cholangiopancreatography (ERCP)

Outcome Measures

Primary Outcomes (1)

• Recurrence of stones in the common bile duct

  The diagnosis of the stone in the common bile duct.

  30 days after ERCP

Secondary Outcomes (10)

• Bleeding

  30 days after ERCP

• Perforation

  30 days after ERCP

• Bile leak

  30 days after ERCP

• Acute cholangitis

  60 days after ERCP

• Bile duct stricture

  1 year after ERCP

Study Arms (2)

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

Procedure: endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy

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

Procedure: endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

Interventions

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.

Also known as: Cholangiopancreatography, Laparoscopic

ERCP, EST and simultaneous LC

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

Also known as: Cholangiopancreatography, Laparoscopic

ERCP, EST and LC in a delayed manner

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moscow Regional Research and Clinical Institute (MONIKI): lead

Study Sites (1)

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

Moscow, Moscow Oblast, 142636, Russia

Location

MeSH Terms

Conditions

Choledocholithiasis; Cholecystolithiasis; Pancreatitis; Gallstones

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Cholecystectomy, Laparoscopic; Laparoscopy

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Gallbladder Diseases; Pancreatic Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cholecystectomy; Biliary Tract Surgical Procedures

Study Officials

• Dmitriy А Pyhteev, PhD

  Head of the Department of Pediatric Surgery

  STUDY DIRECTOR

• Leonid M Elin

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: November 6, 2024
• Study Start: November 13, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 5, 2025
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)