A randomized trial of endoscopic balloon dilation and endoscopic sphincterotomy for removal of bile duct stones in patients with a prior Billroth II gastrectomy

Background: A prior Billroth II gastrectomy renders endoscopic sphincterotomy (EST) more difficult in patients with bile duct stones. Endoscopic balloon dilation (EBD) is a relatively easy procedure that potentially reduces the risk of bleeding and perforation. Methods: Thirty-four patients with bile duct stones and a previous Billroth II gastrectomy were randomized to EST or EBD. Complications were graded in a blinded fashion. Results were compared with those for a group of 180 patients with normal anatomy from a previously reported randomized trial of EBD versus EST. Results: All stones were removed in 1 endoscopic retrograde cholangiopancreatography in 14 of 16 patients who underwent EBD versus 14 of 18 who had EST (p = 1.00). Mechanical lithotripsy was used in 3 EBD procedures versus 4 EST procedures (p = 1.00). Early complications occurred in 3 patients who had EBD versus 7 who underwent EST (p = 0.27). Three patients had bleeding after EST; 1 patient had mild pancreatitis after EBD. The median time required for stone removal was 30 minutes in both groups. Compared with patients with a normal anatomy, patients with a previous Billroth II gastrectomy had a significantly increased risk of bleeding after EST (17% vs. 2%, relative risk = 7.25, p < 0.05). Conclusions: A prior Billroth II gastrectomy renders EST more difficult and increases the risk of a complication. EBD in these patients is easy to perform and is not associated with an increased need for mechanical lithotripsy or a longer procedure time. The risk of bleeding is virtually absent after EBD and the risk of pancreatitis after EBD seems not significantly increased in these patients.