A Prospective Randomized Trial Comparing EUS Guided ERCP Without Fluoroscopy With Standard ERCP in Common Bile Duct Stone Removal

Common bile duct stones (CBDS) can be complicated with various conditions including biliary pain, acute cholangitis, acute pancreatitis and secondary biliary cirrhosis. CBDS should therefore be removed even if patients are asymptomatic.

Endoscopic retrograde cholangiopancreatography (ERCP) is the cornerstone treatment of CBDS. ERCP is often performed under fluoroscopic guidance. This comprises biliary cannulation whereby the bile duct is achieved with a standard ERCP catheter under fluoroscopy guidance, radiocontrast was injected for confirmation and images of biliary system, location and number of CBDS, biliary sphincterotomy was then performed followed by stone extraction using a standard accessories such as a basket and or balloon. Therefore, the endoscopist, endoscopic staff and patient are potentially exposed to ionizing radiation during ERCP. Endoscopists should always attempt to minimize radiation exposure to the personnel staffs and patients by following the ALARA principle ("As Low As Reasonably Achievable"). ERCP without the use of fluoroscopy is the one method to avoid exposure to radiation. A few retrospective case series have been shown that ERCP can be performed with high success rate without the need for fluoroscopic imaging.

EUS has been proven to have diagnostic accuracy comparable to ERCP in the diagnosis of CBDS, and it's associated with a very low procedure related complications and non-radiation exposure procedure. With EUS performed before ERCP, unnecessary ERCP and its related complications can be avoided in patients without CBDS. In patients with CBDS, the images of pancreaticobiliary tract derived from EUS provide an information regarding the location, size and number of CBDS for guiding therapeutic endoscopy, and allowing a therapeutic ERCP in the same session of sedation. Vohra et al. reported the retrospective case series of EUS - based ERCP in 10 pregnant patients, they have shown that EUS performed prior ERCP can eliminate unnecessary ERCP and achieve in CBDS clearance without the use of fluoroscopy. We have previously reported the use of EUS guided ERCP in the removal of CBDS without fluoroscopy (EGWF) in the pilot study, it showed that EGWF was feasible in selected patients with CBDS. The efficacy of EUS guided ERCP in CBDS removal without fluoroscopy compared with standard ERCP has not been fully assessed. We therefore prospectively investigated the efficacy and safety of EGWF versus ERCP in CBDS removal in a larger patient cohort.