Abstract
AIM: To compare gallstones removal rate and incidence of bleeding, pancreatitis, use of mechanical lithotripsy, cholangitis and perforation between isolated sphincterotomy vs 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. 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. RESULTS: Eleven RCTs with 1824 patients were included. EST was associated with more post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding [FE RD-0.02, CI (-0.03, -0.00), I(2) = 33%, P = 0.05] and more need of mechanical lithotripsy in general [RE RD-0.16, CI (-0.25, -0.06), I(2) = 90%, P = 0.002] and in subgroup analysis of stones greater than 15 mm [RE RD-0.20, CI (-0.38, -0.02), I(2) = 82%, P = 0.003]. Incidence of pancreatitis [FE RD-0.01, CI (-0.03, 0.01), I(2) = 0, P = 0.36], cholangitis [FE RD-0.00, CI (-0.01, 0.01), I(2) =0, P = 0.97] and perforation [FE RD-0.01, CI (-0.01, 0.00), I(2) = 0, P = 0.23] was similar between the groups as well as similar stone removal rates in general [FE RD-0.01, CI (-0.01, 0.04), I(2) = 0, P = 0.23] and pooled analysis of stones greater than 15 mm [FE RD-0.02, CI (-0.02, 0.07), I(2) = 11%, P = 0.31]. CONCLUSION: Through meta-analysis of randomized clinical trials we found that isolated sphincterotomy was associated with more post-ERCP bleeding and more need for mechanical lithotripsy. However, there was no statistical difference in the stone removal rate between isolated sphincterotomy and sphincterotomy associated with balloon dilation in the approach to remove gallstones.