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Endoscopic Papillary Large Balloon Dilation Versus Endoscopic Sphincterotomy for Retrieval of Large Choledocholithiasis: A Prospective Randomized Trial.
BACKGROUND: Endoscopic sphincterotomy (ES) is the standard technique for common bile duct (CBD) stone removal. Recently, endoscopic papillary large balloon dilation (EPLBD) has been shown to be a safe and effective technique for the removal of large CBD stone. The aim of this study was to determine the therapeutic outcomes and safety of EPLBD compared with ES for large CBD stone extraction.
PATIENTS AND METHODS: One hundred twenty-four patients with large bile duct stones were randomized into two groups, the first group included 61 patients subjected to EPLBD and the second group included 63 patients who underwent ES. We compared the success rate of stone removal, frequency of mechanical lithotripsy requirement, morbidity, and mortality.
RESULTS: Baseline characteristics were not significantly different. The overall ductal clearance rate was ultimately similar between the EPLBD group (96.7%) and the ES group (93.7%) (P = .53), the one session ductal clearance rate was significantly different (86.9% versus 71.4%; P = .01). Requirement of mechanical lithotripsy was significantly different between the EPLBD and ES group (9.8% versus 17.5%, P = .04). There were no differences in complication rates between the EPLBD and ES group; pancreatitis, 4.9% versus 6.3%; minor hemorrhage, 1.6% versus 6.3%; acute cholangitis, 3.3% versus 1.9%; and recurrent stones, 3.3% versus 3.2%.
CONCLUSIONS: The therapeutic outcomes of EPLBD for removal of large bile duct stones are better than those of ES with comparable complication rate. EPLBD is also recommended for removal of large CBD stone in patients with an underlying coagulopathy or need for anticoagulation following endoscopic retrograde cholangiopancreaticography.
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