Choledocholithiasis
Conditions
Keywords
choledocholithiasis, endoscopic ultrasound, ERCP, intraoperative cholangiography, common bile duct stone, endoscopic retrograde cholangiopancreatography, gallstone disease, cholelithiasis, bile duct obstruction, laparoscopic cholecystectomy
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.
Interventions
PROCEDUREendoscopic ultrasound
Evaluation of bile ducts with endoscope with special ultrasonographic function
PROCEDUREintraoperative cholangiography
evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy
PROCEDUREERCP
evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
DEVICEUltrasound endoscope
Endoscope with built-in ultrasound function
Sponsors
Vilnius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment | up to one month | duration from admission to hospital or decision to perform laparoscopic cholecystectomy to discharge in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of different management strategies | 6 to 7 months | Proportion of correctly diagnosed (true positive and true negative) cases in all sample |
| 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 |
| Costs of treatment | up to one month | charges of diagnostic procedures, invasive procedures, surgery, antibacterial treatment if needed and hospital charges |
Countries
Lithuania
Outcome results
None listed