"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis
NCT ID: NCT03658863
Last Updated: 2019-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
106 participants
INTERVENTIONAL
2017-12-15
2020-12-15
Brief Summary
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Endosonoscopic evaluation of bile ducts and endoscopic retrograde cholangiography (ERCP) on demand are performed before laparoscopic cholecystectomy for one arm. Intraoperative cholangiography during laparoscopic cholecystectomy and postoperative ERCP on demand are administered in another arm.
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Detailed Description
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At the Centre of Abdominal Surgery of Vilnius University Hospital Santaros klinikos an original prognostic index (Vilnius University Hospital index (VUHI)) is used for evaluation of risk of choledocholithiasis. It is calculated by formula VUHI = A/30 + 0.4×B, where A - total bilirubin concentration (µmol/l), B - common bile duct (CBD) diameter measured by ultrasound exam. A retrospective study evaluated its accuracy and determined threshold values for low, intermediate and high risk groups. The intermediate risk group (risk for choledocholithiasis 25-75%) would benefit from additional examination before ERCP. Endoscopic ultrasound (EUS) and intraoperative cholangiography are less invasive procedures with high accuracy identifying common bile duct stones. Main hypothesis of the trial is that intraoperative cholangiography with ERCP on demand can shorten the duration and costs of treatment and avoid diagnostic ERCPs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Endoscopy first
Endoscopic ultrasound is used to evaluate bile ducts. If stones in extrahepatic bile ducts are seen ERCP and stone evacuation is performed during the same anaesthesia. Laparoscopic cholecystectomy is performed after endoscopic procedures in two days.
endoscopic ultrasound
Evaluation of bile ducts with endoscope with special ultrasonographic function
ERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
Ultrasound endoscope
Endoscope with built-in ultrasound function
Cholecystectomy first
Laparoscopic cholecystectomy with intraoperative cholangiography is performed. If stones are found postoperative ERCP with stone evacuation is applied (during cholecystectomy if common bile duct is completely blocked or as soon as possible).
intraoperative cholangiography
evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy
ERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
Interventions
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endoscopic ultrasound
Evaluation of bile ducts with endoscope with special ultrasonographic function
intraoperative cholangiography
evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy
ERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
Ultrasound endoscope
Endoscope with built-in ultrasound function
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* intermediate risk for choledocholithiasis (VUHI 2,6 - 6,9 and one of the predictors: dilated common bile duct, elevated total bilirubin or suspected stone in CBD on ultrasound)
Exclusion Criteria
* acute cholangitis;
* biliary pancreatitis;
* acute cholecystitis, degree II-III by Tokyo guidelines 2013;
* anastomosis in upper gastrointestinal tract;
* other known cholestatic hepatopancreatobiliary disease;
* known or suspected hepatitis of another origin (viral, toxic, etc.);
* contraindications for general anaesthesia or surgery;
* IV-VI class of American Society of Anesthesiologists physical status classification;
* morbid obesity (body mass index \> 40);
* patient's refusal to participate in the study.
18 Years
80 Years
ALL
No
Sponsors
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Vilnius University
OTHER
Responsible Party
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Ausra Aleknaite
Investigator
Locations
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Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
Countries
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Facility Contacts
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References
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Aleknaite A, Simutis G, Stanaitis J, Jucaitis T, Drungilas M, Valantinas J, Strupas K. Comparison of Endoscopy First and Laparoscopic Cholecystectomy First Strategies for Patients With Gallstone Disease and Intermediate Risk of Choledocholithiasis: Protocol for a Clinical Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 4;10(2):e18837. doi: 10.2196/18837.
Other Identifiers
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TLA02
Identifier Type: -
Identifier Source: org_study_id
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