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

Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06672991
Enrollment
25
Registered
2024-11-04
Start date
2024-11-21
Completion date
2025-02-05
Last updated
2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Children, Endoscopic retrograde cholangiopancreatography (ERCP), Сholedocholelysis, 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).

Interventions

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 on a delayed basis, 7 to 15 days after ERCP in a single hospitalization

Sponsors

Moscow Regional Research and Clinical Institute (MONIKI)
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Informed consent from child or legal guardian * Age 0-18 years * Acute cholecystitis * Choledocholithiasis

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of common bile duct stones60 days after ERCPThe diagnosis of the stone in the common bile duct was made by MRI, CT scan and ultrasound, if confirmed, before performing laparoscopic cholecystectomy.

Secondary

MeasureTime frameDescription
Acute pancreatitis30 days after ERCPat least two out of three criteria according to the classification developed by the INSPPIRE group
Duration of the laparoscopic cholecystectomy,minFrom enrollment to the end of treatment (3 month)
Bleeding30 days after ERCP
Perforation30 days after ERCPby CT, radiography (fluid or gas in the retroperitoneal space or abdominal cavity, visual picture during endoscopic examination)
Technical success1 month\- success of the procedures as documented by a yes or no
Acute cholangitis60 days after ERCPintermittent chills, fever, increased proinflammatory blood markers after ERCP
Bile duct stricture1 year after ERCPafter ERCP
Time spent in hospital until dischargefrom admission to hospital until the end of treatment (up to 8 weeks)
Duration of the Endoscopic retrograde cholangiopancreatography,minFrom enrollment to the end of treatment (3 month)
Bile leak30 days after ERCPbile aspirated from the abdominal cavity

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026