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

Moscow Regional Research and Clinical Institute (MONIKI)

Status: Enrolling

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

Treatments: Procedure: endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy; Procedure: endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06676241

16/17.10.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: Under 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent from the patient, child or legal representative
• Age 0-55 years
• Acute cholecystitis
• Choledocholithiasis
• Intraoperative ERCP
• Preoperative ERCP followed by cholecystectomy

Exclusion criteria

• Unwillingness or inability to consent to the study
• Pregnancy
• Age > 55 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

Trial design

70 participants in 2 patient groups

ERCP, EST and simultaneous LC

Description:

Patients aged 18-55 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

Treatment:

Procedure: endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomy

ERCP, EST and LC in a delayed manner

Description:

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

Treatment:

Procedure: endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomy