Background and aim: Endoscopic ultrasonography (EUS) is a minimally invasive diagnostic tool for common bile duct stones (CBDS) and may be used to select patients for therapeutic endoscopic retrograde cholangiography (ERC). The aim of this trial is to compare, in patients with non-high-risk for CDBS, the clinical and economic impact of EUS plus ERC performed in a single endoscopic session versus EUS plus ERC in two separate sessions.
Methods: During an 11-month period, all adult patients admitted to the emergency department with suspicion of CBDS were categorized into either high-risk or non-high-risk groups, on the basis of clinical, biochemical, or transabdominal ultrasound findings. Patients in the non-high-risk group were randomized to receive EUS plus ERC in one single or in two separate sessions.
Results: Eighty patients were recruited and randomized. Forty patients underwent EUS plus ERC in a single session and 40 patients underwent EUS plus ERC in two separate sessions. Negative EUS examination for CBDS avoided unnecessary ERC to 33 patients. Out of 47 patients with positive EUS (25 from the single session group and 22 from the double session), ERC confirmed the presence of CBDS in 46 cases (EUS sensitivity 100% and specificity 98%). Average time of procedure and hospitalization were significantly shorter in the single session group compared to the two session group. The single session strategy was also less expensive.
Conclusion: Endoscopic ultrasonography plus ERC with sphincterotomy and stone extraction performed during the same endoscopic session was safe and efficacious with a reduction of procedure time, hospitalization and costs.