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

Moscow Regional Research and Clinical Institute (MONIKI)44 enrolled

Overview

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.

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

Conditions

Choledocholithiasis

Interventions

endoscopic retrograde cholangiopancreatography; laparoscopic cholecystectomyPROCEDURE

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.

endoscopic retrograde cholangiopancreatography;laparoscopic cholecystectomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 0 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recurrence of stones in the common bile duct

The diagnosis of the stone in the common bile duct.

Time frame: 30 days after ERCP

Secondary Outcomes

Bleeding

decreased hemoglobin level, visual picture during endoscopic examination, positive stool for occult blood

Time frame: 30 days after ERCP

Perforation

by CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)

Time frame: 30 days after ERCP

Bile leak

bile aspirated from the abdominal cavity

Time frame: 30 days after ERCP

Acute cholangitis

intermittent chills, fever, increased proinflammatory blood markers after ERCP

Time frame: 60 days after ERCP

Bile duct stricture

after ERCP

Time frame: 1 year after ERCP

Time spent in hospital until discharge

Time frame: 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

Time frame: 1 month

Duration of the laparoscopic cholecystectomy,min

Time frame: From enrollment to the end of treatment (3 month)

Acute pancreatitis

at least two out of three criteria according to the classification developed by the INSPPIRE group

Time frame: within 14 days after ERCP

Duration of the Endoscopic retrograde cholangiopancreatography

Time frame: From enrollment to the end of treatment (3 month)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes