Clinical trial NCT06676241: One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis
Official title: One-stage and Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography with Endoscopic Sphincterotomy in Cholecystocholedocholithiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis
Cholecystolithiasis
Cholangiopancreatography, Endoscopic Retrograde
Laparoscopic Cholecystectomy
Children
Acute Pancreatitis (AP)
Common Bile Duct Calculi
Keywords: Сholedocholelysis
Endoscopic retrograde cholangiopancreatography (ERCP)
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2024-11-06
Enrollment: 44
Sex: ALL
Minimum age (years): 0
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moscow Regional Scientific Research Clinical Institute named after M.F. Vladimirsky

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of stones in the common bile duct
timeFrame: 30 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 - success of the procedures as documented by a yes or no
timeFrame: 1 month
measure: Duration of the laparoscopic cholecystectomy,min
timeFrame: From enrollment to the end of treatment (3 month)
measure: Acute pancreatitis
timeFrame: within 14 days after ERCP
measure: Duration of the Endoscopic retrograde cholangiopancreatography
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: Moscow region
Study officials:
affiliation: Head of the Department of Pediatric Surgery
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: