AIM:To perform a meta-analysis of large-balloon dilation(LBD)plus endoscopic sphincterotomy(EST)vs EST alone for removal of bile duct stones.METHODS:Databases including PubMed,EMBASE,the Cochrane Library,the Science Citation Index,and important meeting abstracts were searched and evaluated by two reviewers independently.The main outcome measures included:complete stone removal,stone removal in the first session,use of mechanical lithotripsy,procedure time,and procedure-related complications.A fixed-effects model weighted by the Mantel-Haenszel method was used for pooling the odds ratio(OR)when heterogeneity was not significant among the studies.When a Q test or I2statistic indicated substantial heterogeneity,a random-effects model weighted by the DerSimonian-Laird method was used.RESULTS:Six randomized controlled trials involving835 patients were analyzed.There was no significant heterogeneity for most results;we analyzed these using a fixed-effects model.Meta-analysis showed EST plus LBD caused fewer overall complications than EST alone(OR=0.53,95%CI:0.33-0.85,P=0.008);sub-category analysis indicated a significantly lower risk of perforation in the EST plus LBD group(Peto OR=0.14,95%CI:0.20-0.98,P=0.05).Use of mechanical lithotripsy in the EST plus LBD group decreased significantly(OR=0.26,95%CI:0.08-0.82,P=0.02),especially in patients with a stone size larger than 15 mm(OR=0.15,95%CI:0.03-0.68,P=0.01).There were no significant differences between the two groups regarding complete stone removal,stone removal in the first session,post-endoscopic retrograde cholangiopancreatography pancreatitis,bleeding,infection of biliary tract,and procedure time.CONCLUSION:EST plus LBD is an effective approach for the removal of large bile duct stones,causing fewer complications than EST alone.