UnknownNot Applicable

"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis

Lithuania106 participantsStarted 2017-12-15

Plain-language summary

The study compares two different methods to evaluate extrahepatic bile ducts for possible stones for patients with cholecystolithiasis and intermediate risk for choledocholithiasis when laparoscopic cholecystectomy is indicated. 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients with cholecystolithiasis when laparoscopic cholecystectomy is indicated * 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: * pregnancy; * 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.

What they're measuring

Duration of treatment

Timeframe: up to one month

Trial details

NCT IDNCT03658863

SponsorVilnius University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-15