ERCP and LC for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?

Recruiting

Conditions: Choledocholithiasis
Cholecystolithiasis
Cholangiopancreatography, Endoscopic Retrograde
Laparoscopic Cholecystectomy in Children
Children
Common Bile Duct Calculi

Brief Summary: Chronic calculous cholecystitis in pediatric patients leads to choledocholithiasis in about 12% of cases. These patients require removal of stones from the common bile duct. The most common method of cleaning the common bile duct is endoscopic retrograde cholangiopancreatography, and the standard technique for removing the gallbladder is laparoscopic cholecystectomy. There are different approaches to the treatment of this category of patients: laparoscopic common bile duct exploration (LCBDE), laparoendoscopic rendezvous method (LERV) and one-stage LC after ERCP. Given the inflammation of the gallbladder and the inflammatory process in the hepatoduodenal ligament, early laparoscopic cholecystectomy can lead to various intraoperative complications. The aim of this retrospective study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with laparoscopic cholecystectomy in a delayed manner (single or repeated hospitalization).

Detailed Description: There is no gold standard for the treatment of cholecystocholedocholithiasis in the pediatric population. The most common method for resolving biliary obstruction is endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) and laparoscopic cholecystectomy (LC). There are different approaches to the treatment of cholecystocholedocholithiasis: 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, many medical institutions do not have the opportunity to use these methods due to the difficulties of implementation and the need for specialized training and experience of specialists. The timing of LC after ERCP in patients with cholecystocholedocholithiasis remains a subject of debate. The present study aims to compare ERCP with ES + delayed LC in intra- and re-hospitalization in pediatric patients with cholecystocholedocholithiasis.

The aim of this study is to evaluate the efficacy and safety of endoscopic retrograde cholangiopancreatography, endoscopic sphincterotomy with laparoscopic cholecystectomy in a delayed manner (single or repeated hospitalization).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Unwillingness or inability to consent to the study
Previous ERCP or percutaneous transhepatic biliary drainage
Benign or malignant stricture
Preoperative comorbidities: gastrointestinal bleeding, severe liver disease, acute and chronic cholangitis, septic shock.
In combination with Mirizzi syndrome and intrahepatic bile duct stones
Congenital anomaly of the biliary tract
Malignant neoplasms
Acute pancreatitis before the procedure

Primary Outcome Measures

Name	Time	Method
Recurrence of common bile duct stones	60 days after ERCP	The diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound, if confirmed, before performing laparoscopic cholecystectomy.

Secondary Outcome Measures

Name	Time	Method
Bleeding	30 days after ERCP
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	1 month	- success of the procedures as documented by a yes or no
Acute pancreatitis	30 days after ERCP	at least two out of three criteria according to the classification developed by the INSPPIRE group
Duration of the laparoscopic cholecystectomy,min	From enrollment to the end of treatment (3 month)
Duration of the Endoscopic retrograde cholangiopancreatography,min	From enrollment to the end of treatment (3 month)

Locations (1): Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
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Moscow, Московская область, Russian Federation