AIM:To evaluate the efficacy and safety of endoscopic sphincterotomy(EST) + endoscopic papillary large balloon dilation(EPLBD)vs isolated EST.METHODS:We conducted a retrospective single center study over two years,from February 2010 to January 2012.Patients with large(≥ 10 mm),single or multiple bile duct stones(BDS),submitted to endoscopic retrograde cholangio-pancreatography(ERCP) were included.Patients in Group A underwent papillary large balloon dilation after limited sphincterotomy(EST+EPLBD),using a through-the-scope balloon catheter gradually inflated to 12-18 mm according to the size of the largest stone and the maximal diameter of the distal bile duct on the cholangiogram.Patients in Group B(control group) underwent isolated sphincterotomy.Stones were removed using a retrieval balloon catheter and/or a dormia basket.When necessary,mechanical lithotripsy was performed.Complete clearance of the bile duct was documented with a balloon catheter cholangiogram at the end of the procedure.In case of residual lithiasis,a double pigtail plastic stent was placed and a second ERCP was planned within 4-6 wk.Some patients were sent for extracorporeal lithotripsy prior to subsequent ERCP.Outcomes of EST+EPLBD(Group A) vs isolated EST(Group B) were compared regarding efficacy(complete stone clearance,number of therapeutic sessions,mechanical and/or extracorporeal lithotripsy,biliary stent placement) and safety(frequency,type and grade of complications).Statistical analysis was performed using χ 2 or Fisher’s exact tests for the analysis of categorical parameters and Student’s t test for continuous variables.A P-value of less than 0.05 was considered statistically significant.RESULTS:One hundred and eleven patients were included,68(61.3%) in Group A and 43(38.7%) in Group B.The mean diameter of the stones was similar in the two groups(16.8 ± 4.4 and 16.0 ± 6.7 in Groups A and B,respectively).Forty-eight(70.6%) patients in Group A and 21(48.8%) in Group B had multiple BDS(P = 0.005).Overall,balloon dilation was performed up to 12 mm in 10(14.7%) patients,13.5 mm in 17(25.0%),15 mm in 33(48.6%),16.5 mm in 2(2.9%) and 18 mm in 6(8.8%) patients,taking into account the diameter of the largest stone and that of the bile duct.Complete stone clearance was achieved in sixty-five(95.6%) patients in Group A vs 30(69.8%) patients in Group B,and was attained within the first therapeutic session in 82.4% of patients in Group A vs 44.2% in Group B(P < 0.001).Patients submitted to EST+EPLBD underwent fewer therapeutic sessions(1.1 ± 0.3 vs 1.8 ± 1.1,P < 0.001),and fewer required mechanical(14.7% vs 37.2%,P = 0.007) or extracorporeal(0 vs 18.6%,P < 0.001) lithotripsy,as well as biliary stenting(17.6% vs 60.5%,P < 0.001).The rate of complications was not significantly different between the two groups.CONCLUSION:EST+EPLBD is a safe and effective technique for treatment of difficult BDS,leading to high rates of complete stone clearance and reducing the need for lithotripsy and biliary stenting.
