Prospective randomized trial of EUS-assisted ERCP without fluoroscopy versus ERCP in common bile duct stones.

BACKGROUND AND AIMS: ERCP with stone removal is the standard treatment for common bile duct stones (CBDSs). Radiation exposure is a risk to the endoscopist and patient. EUS-guided ERCP without fluoroscopy (EGEWF) in patients with CBDSs is feasible, but the efficacy and safety compared with ERCP is unknown. We aimed to compare the efficacy and safety of EGEWF with ERCP in CBDS removal.

METHODS: A prospective randomized study was done in 114 patients with CBDSs who met inclusion criteria. These patients were equally randomized into the EGEWF and ERCP groups. In the EGEWF group, ERCP was performed by cannulation without fluoroscopy. Balloon sweeping was done after sphincterotomy to clear the stones until the number of stones matched the number detected by EUS and the stone clearance (SC) was confirmed by cholangiography. In the ERCP group, ERCP was performed in the standard manner. The cannulation rates, SC rates, total procedure and fluoroscopic times, and adverse event rates were analyzed.

RESULTS: After exclusion of 3 patients, 55 were in the EGEWF group and 56 in the ERCP group. Demographic data, laboratory data, stone characteristics, CBD diameter, and number of patients with periampullary diverticulum were not different between the 2 groups. The cannulation success rates in the EGEWF (96.35%) and ERCP (100%) groups were similar (P = .243). The SC rate in the EGEWF group (85.5%) was inferior to the ERCP group (100%) (P = .002). The SC rate based on the number of stones retrieved that matched the number by EUS was correct in 94%. More than 2 stones may increase the failure rate of SC in EGEWF. The adverse event rates and the total procedure times were not different between the groups.

CONCLUSIONS: EGEWF was inferior to ERCP in terms of SC; however, no radiation exposure is beneficial for selected patients. (Clinical trial registration number: NCT02870686.).