"Endoscopy First" or "Laparoscopic Cholecystectomy First" for Patients With Intermediate Risk of Choledocholithiasis
- Conditions
- Choledocholithiasis
- Interventions
- Procedure: endoscopic ultrasoundProcedure: intraoperative cholangiographyProcedure: ERCPDevice: Ultrasound endoscope
- Registration Number
- NCT03658863
- Lead Sponsor
- Vilnius University
- Brief 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.
- Detailed Description
Use of ERCP as a diagnostic tool should be minimized as it carries considerable risk (5 to 10%) of post-procedural complications. It is noticed that adverse events occur more often to patients with low risk of choledocholithiasis. Therefore the best possible patient selection for ERCP procedure is needed.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 106
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Endoscopy first ERCP 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. Endoscopy first endoscopic ultrasound 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. Cholecystectomy first intraoperative cholangiography 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). Endoscopy first Ultrasound endoscope 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. Cholecystectomy first ERCP 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).
- Primary Outcome Measures
Name Time Method Duration of treatment up to one month duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days
- Secondary Outcome Measures
Name Time Method Accuracy of different management strategies 6 to 7 months Proportion of correctly diagnosed (true positive and true negative) cases in all sample
Costs of treatment up to one month charges of diagnostic procedures, invasive procedures, surgery, antibacterial treatment if needed and hospital charges
Technical success of interventions (IOC, EUS, ERCP) up to one month For intraoperative cholangiography: successful cannulation and contrast media injection into CBD.
For endoscopic sonoscopy: successful visualisation of CBD.
For ERCP: successful cannulation and contrast media injection into CBD.Adverse events of interventions up to one month Bleeding, acute pancreatitis, perforation, allergic reactions
Trial Locations
- Locations (1)
Vilnius University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania