Aim: To compare gallstones removal rate and incidence of bleeding, pancreatitis, use of mechanical lithotripsy, cholangitis and perforation between isolated sphincterotomy versus sphincterotomy associated with balloon dilation of papilla in choledocholithiasis through the meta-analysis of randomized clinical trials. Methods: We conducted a systematic review according to the PRISMA guidelines. Literature search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane Library, LILACS, and EMBASE database platforms in July 2017. Eligibility criteria: Participants: patients with choledocholithiasis, older than 18 years. Interventions and comparisons: to compare endoscopic isolated sphincterotomy vs endoscopic sphincterotomy associated with balloon dilation. All relevant articles were accessed in full text. The manual search included references of retrieved articles. We extracted data focusing on outcomes: The primary endpoint was the stones removal rate; Secondary endpoints were rates of pancreatitis, bleeding, use of mechanical lithotripsy (ML), perforation and cholangitis. We analyzed the data and reported the results in tables and text. Results: Nine RCTs with a total of 1230 patients were included. Data analysis of the included studies showed that there was no statistical difference in safety between the two methods, since the incidence of pancreatitis (FE RD -0.01, CI [-0.03, 0.02], I 2 Z 0, p Z 0.5), bleeding (FE RD -0.01, CI [-0.03, 0.01], I 2 Z 32%, p Z 0.25), cholangitis (FE RD 0.00, CI[-0.01, 0.01], I 2 Z0, p Z 0.98) and perforation (FE RD -0.01, CI [-0.02, 0.01], I 2 Z0, p Z 0.37) was similar between the groups, but it was evident that there was a difference in efficacy, not quantitatively, with similar removal rates of gallstones in general and for subgroups greater than 15mm (FE RD 0.01, CI [-0.02, 0.04], I 2 Z 0, p Z 0.59) and (FE RD 0.02, CI [-0.04, 0.07], I 2 Z 5%, p Z 0.52), respectively, but perhaps qualitative, since there was less need for mechanical lithotripsy in the ESBD group (RE RD -0.14, CI [-0.25, -0.03], I 2 Z 91%, p Z 0.01), with a consequent theoretical decrease in exposure to adverse events resulting from it. Conclusion: There was no difference in the stone removal rate and incidence of bleeding, pancreatitis, cholangitis and perforation between isolated sphincterotomy and sphincterotomy associated with balloon dilation in the approach to remove gallstones. However, there was less use of mechanical lithotripsy in patients with choledocholithiasis submitted to sphincterotomy associated with balloon dilation.