Endoscopic papillary balloon dilation vs. sphincterotomy for removal of common bile duct stones: a prospective randomized pilot study.

Abstract

Endoscopic sphincterotomy (EST) is the standard procedure for gaining access to the common bile duct for removal of bile duct stones. However, the procedure is associated with both short-term and long-term complications. Recent reports have described the use of endoscopic papillary balloon dilation (EBD) as an effective and safe alternative to EST. We conducted a prospective randomized pilot study to compare the efficacy and short-term complication rates of these two established methods for removing uncomplicated bile duct stones. Sixty patients were randomly assigned to receive either EST (n = 30) or EBD (n = 30) prior to removal of bile duct stones (maximum size 20 mm, maximum number five). The patient groups were comparable with regard to sex and age ratios, the size of the stones (EST: mean 10 +/- 4.7 mm; EBD: mean 7 +/- 3.5 min; not significant) and the numbers of stones (EST: mean 1.8 +/- 1.5 mm; EBD: mean 1.6 +/- 1.1 mm; not significant). EBD was carried out using a balloon-tipped biliary catheter (Maxforce, Microvasive, Boston, Massachusetts, USA) with a maximum diameter of 24 Fr for 45-60 s. Bile duct stones were removed using Dormia baskets or retrieval balloons, or both. The two methods were successful in all patients studied. Subsequent stone removal was possible in all 30 patients after EST (100%) and in 23 of the 30 who underwent EBD (77%), respectively (P<0.01). After conversion to EST, complete bile duct clearance was also achieved in the remaining seven EBD patients. The mean duration for the whole procedure was 17 +/- 12 min for EST and 29 +/- 15 min for EBD (not significant). Complications (WHO grades 2-4) were observed in five of the 30 EST patients (three cases of mild pancreatitis, two of hemorrhage) and in nine of the 30 EBD patients (three cases of cholangitis, four of mild pancreatitis, and two of severe pancreatitis), showing a trend toward higher complication rates in the EBD group. Postintervention hyperamylasemia was observed in six patients (three in each group). The results of this prospective randomized pilot study indicate that EST is superior to EBD in terms of stone removal, duration of the procedure, and complication rates. EST will therefore continue to be the standard procedure for stone removal in the near future. Further studies will be needed in order to compare the longer-term results with EST and EBD.