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.

Study Overview

• Status: Completed
• Conditions: Children; Cholecystolithiasis; Laparoscopic Cholecystectomy; Choledocholithiasis; Common Bile Duct Calculi; Cholangiopancreatography, Endoscopic Retrograde; Acute Pancreatitis (AP)
• Intervention / Treatment: Procedure: endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy; Procedure: endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

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.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow region
    • Moscow, Moscow region, Russian Federation, 142636
      • Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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: Laparoscopic; Cholangiopancreatography
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; 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: Laparoscopic; Cholangiopancreatography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of stones in the common bile duct	The diagnosis of the stone in the common bile duct.	30 days after ERCP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perforation	by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)	30 days after ERCP
Bile leak	bile aspirated from the abdominal cavity	30 days after ERCP
Acute cholangitis	intermittent chills, fever, increased proinflammatory blood markers after ERCP	60 days after ERCP
Bile duct stricture	after ERCP	1 year after ERCP
Time spent in hospital until discharge		from admission to hospital until the end of treatment (up to 8 weeks)
Duration of the laparoscopic cholecystectomy,min		From enrollment to the end of treatment (3 month)
Bleeding	decreased hemoglobin level, visual picture during endoscopic examination, positive stool for occult blood	30 days after ERCP
Technical success - success of the procedures as documented by a yes or no		1 month
Acute pancreatitis	at least two out of three criteria according to the classification developed by the INSPPIRE group	within 14 days after ERCP
Duration of the Endoscopic retrograde cholangiopancreatography		From enrollment to the end of treatment (3 month)

Collaborators and Investigators

• Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
• Investigators: Principal Investigator: Leonid M Elin, Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky; Study Director: Dmitriy А Pyhteev, PhD, Head of the Department of Pediatric Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Endoscopic retrograde cholangiopancreatography (ERCP); Сholedocholelysis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Pancreatic Diseases; Biliary Tract Diseases; Bile Duct Diseases; Gallbladder Diseases; Common Bile Duct Diseases; Pancreatitis; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis; Choledocholithiasis
• Other Study ID Numbers: 16/17.10.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A complete dataset can be provided upon reasoned request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No