Choledocholithiasis Clinical Trial
Official title:
Comparison of Two Management Strategies, "Endoscopy First" and "Laparoscopic Cholecystectomy First", for Patients With Gallbladder Stones and Intermediate Risk for Choledocholithiasis
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.
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.
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