Background and Study Aims: We studied the rate of pancreatitis and asymptomatic hyperamylasemia after endoscopic balloon dilation (EBD) and endoscopic sphincterotomy (EST) for removal of bile duct stones, Patients and Methods: Patients with bile duct stones of all sizes were randomly allocated to undergo EBD (8-mm dilation balloon) or EST, Pancreatitis was defined as epigastric pain combined with at least a threefold rise in serum amylase at 24 hours after the endoscopic retrograde cholangiopancreatography (ERCP), Asymptomatic hyperamylasemia was defined as a threefold rise in serum amylase without epigastric pain, Results: There were 180 patients (67 men, 113 women; mean age 67, SD 16.2) available for analysis, Complete stone removal after a single ERCP was achieved in 82 (88 %) of 93 EBD patients and in 81 (93 %) of 87 EST patients (P = 0.38), Mechanical lithotripsy was used more frequently in the EBD group (31% vs, 13%, P = 0.005), Early complications occurred in 16 EBD patients (17 %) and in 19 EST patients (22 %) (P = 0.46), Pancreatitis was observed in seven patients in each group (8 %), Logistic regression identified no significant predictors for the occurrence of pancreatitis, Asymptomatic hyperamylasemia occurred in 21 EBD patients (23 %) vs seven EST patients (8 %) (P = 0.008), Logistic regression identified EBD as the only significant predictor for asymptomatic hyperamylasemia: odds ratio 2.9 (95 % confidence interval (CI) 1.1 to 7.3, R-2 = 0.02), Conclusions: We did not observe a difference in the rate of pancreatitis between EBD and EST, Asymptomatic hyperamylasemia was observed more frequently after EBD, Although asymptomatic hyperamylasemia is not a clinical entity, this finding may indicate that EBD causes more irritation of the pancreas than EST.