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

Recruiting

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

• Registration Number: NCT06676241
• Lead Sponsor: Moscow Regional Research and Clinical Institute (MONIKI)

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.

Study Timeline

• Study First Submitted: 2024-10-27
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-06
• Study Start: 2024-11-13
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of stones in the common bile duct	30 days after ERCP	The diagnosis of the stone in the common bile duct.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky; 🇷🇺 Moscow, Moscow region, Russian Federation