Objective:To evaluate the clinical efficacy of limited endoscopic sphincterotomy with balloon dilation(ESBD) in the treatment of common bile duct stones by comparing the efficacy and safety of the two methods,ESBD and endoscopic sphincterotomy (EST). Methods:Between 2013 and 2015,300 consecutive patients with common bile duct stones were randomly assigned to groups that underwent EST or ESBD. Patients in the ESBD group underwent limited sphincterotomy(1/3 up to half of the sphincter) followed by balloon dilation to the size of the common bile duct or 15 mm,and patients in the EST group underwent complete sphincterotomy alone. Stones were removed using standard techniques. The primary outcome was percentage of stones cleared,and secondary outcomes included procedural time,method of stone extraction,number of procedures required for stone clearance,morbidities and other complications. Results:There was no significant difference between groups in percentage of stones cleared(EST vs. ESBD:100% vs.100%). Complete stone removal in the first session was accomplished at higher rates with ESBD than with EST, particularly for stones ≥15 mm (75.9% vs. 90.4%,P < 0.05). And ESBD was faster compared to ESD for large stones. More patients in the EST group (38.0%) than the ESBD group (23.3%) required mechanical lithotripsy (P < 0.05),particularly for stones ≥15 mm (87.0% vs. 57.7%,P < 0.05). Morbidities developed in 5.3% of patients in the EST group and 4% of patients in the ESBD group (P ≥ 0.05). Conclusion:ESBD and EST clear bile stones with equal efficacy. However,ESBD reduces the need for mechanical lithotripsy and is higher complete stone removal in the first session and faster compared to EST for large stones.