Clinical trial NCT06672991: ERCP and LC for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?
Official title: Endoscopic Retrograde Cholangiopancreatography and Laparoscopic Cholecystectomy for Cholecystocholedocholithiasis in Children: Should It Be Accomplished in One or Repeated Hospitalization?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis
Cholecystolithiasis
Cholangiopancreatography, Endoscopic Retrograde
Laparoscopic Cholecystectomy in Children
Children
Common Bile Duct Calculi
Keywords: Children
Endoscopic retrograde cholangiopancreatography (ERCP)
Сholedocholelysis
Common Bile Duct Calculi
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2024-11-04
Enrollment: 25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children under 18 years of age diagnosed with cholecystocholedocholithiasis

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).

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of common bile duct stones
timeFrame: 60 days after ERCP
Secondary outcomes:
measure: Bleeding
timeFrame: 30 days after ERCP
measure: Perforation
timeFrame: 30 days after ERCP
measure: Bile leak
timeFrame: 30 days after ERCP
measure: Acute cholangitis
timeFrame: 60 days after ERCP
measure: Bile duct stricture
timeFrame: 1 year after ERCP
measure: Time spent in hospital until discharge
timeFrame: from admission to hospital until the end of treatment (up to 8 weeks)
measure: Technical success
timeFrame: 1 month
measure: Acute pancreatitis
timeFrame: 30 days after ERCP
measure: Duration of the laparoscopic cholecystectomy,min
timeFrame: From enrollment to the end of treatment (3 month)
measure: Duration of the Endoscopic retrograde cholangiopancreatography,min
timeFrame: From enrollment to the end of treatment (3 month)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
state: Московская область
Study officials:
affiliation: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
name: Dmitriy А Pyhteev, PhD
role: STUDY_DIRECTOR
affiliation: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky
name: Leonid M Elin
role: PRINCIPAL_INVESTIGATOR
References: