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The removal of large bile duct stones (>12 mm) after endoscopic sphincterotomy (EST) remains a challenging issue in therapeutic endoscopy. The aim of this prospective, randomized, controlled trial was to compare the effectiveness and complications of EST followed by large balloon dilation (LBD) with that of EST followed by mechanical lithotripsy (ML) for the management of large bile duct stones.A total of 90 patients with large bile duct stones (12–20 mm) were randomized to EST followed by LBD (n=45) or EST followed by ML (n=45). Success rate was determined with a final cholangiogram, whereas type and rate of post-procedure complications were assessed prospectively.Complete bile duct stone removal was accomplished in 97.7% of patients subjected to EST–LBD as compared with 91.1% of those subjected to EST–ML (P=0.36). Post-procedure complications were observed in two (4.4%) patients subjected to EST–LBD and in nine (20%) patients subjected to EST–ML (P=0.049). Rates of pancreatitis were similar between the two groups (one case in each), as was post-endoscopic retrograde cholangio pancreatography (ERCP) hemorrhage (one case in each group). None of the patients subjected to EST–LBD developed cholangitis, while this was seen in six patients subjected to EST–ML (0.0 vs. 13.3%,P=0.026). One patient subjected to EST–ML developed perforation, which was successfully managed conservatively. None of our patients with complications died.EST followed by LBD is equally effective as EST followed by ML for the removal of large bile duct stones, although it is associated with fewer complications.