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Background and study aims  Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones. Methods  Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed. Results  There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group ( P  < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; P  < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; P  = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones. Conclusions Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.Trial registered at ClinicalTrials.gov (NCT02592811)., Competing Interests: Competing interests: None, (© Georg Thieme Verlag KG Stuttgart · New York.)

Endoscopic sphincterotomy (ES) is the standard therapy in common bile duct (CBD) stones extraction. Large stones (≥ 12 mm) or multiple stones extraction may be challenging after ES alone. Endoscopic sphincterotomy followed by large balloon dilation (ESLBD) has been described as an alternative to ES in these indications. Efficacy, safety, cost-effectiveness and technical aspects of the procedure have been here reviewed. PubMed and Google Scholar search resulted in forty-one articles dealing with CBD stone extraction with 12 mm or more dilation balloons after ES. ESLBD is at least as effective as ES, and reduces the need for additional mechanical lithotripsy. Adverse events rates are not statistically different after ESLBD compared to ES for pancreatitis, bleeding and perforation. However, particular attention should be paid in patients with CBD strictures, which is identified as a risk factor of perforation. ESLBD is slightly cost-effective compared to ES. A small sphincterotomy is usually performed, and may reduce bleeding rates compared to full sphincterotomy. Dilation is performed with 12-20 mm enteral balloons. Optimal inflation time is yet to be determined. The procedure can be performed safely even in patients with peri-ampullary diverticula and surgically altered anatomy. ESLBD is effective and safe in the removal of large CBD stones, however, small sphincterotomy might be preferred and CBD strictures should be considered as a relative contraindication.

Objective: Endoscopic sphincterotomy plus large-balloon dilatation (ESLBD) has an efficacy equal to or higher than that of endoscopic sphincterotomy alone for biliary lithiasis extractions. Our purpose was to evaluate the feasibility, efficacy and morbidity of large-balloon dilatation of the sphincter of Oddi after sphincterotomy or infundibulotomy for large or multiple common bile duct stones., Material and Methods: Retrospective analysis., Results: A total of 64 ESLBD procedures were performed in 62 patients: 57 after sphincterotomy and 7 after infundibulotomy. The feasibility was 100%, and full clearance of the common bile duct was achieved in a single session without using mechanical lithotripsy in 95.3% of cases. Short-term complications were observed in 9 patients (14%). There were no perforations. The most frequent complication was delayed bleeding (7.8%). There was no significant difference of overall complications after sphincterotomy or after infundibulotomy (12.3% vs. 28.6%, p = 0.25). The incidence of acute pancreatitis was significantly higher after infundibulotomy than after sphincterotomy (28.6% vs. 0%, p = 0.01)., Conclusions: ESLBD after endoscopic sphincterotomy or infundibulotomy is a simple, reproducible and effective technique, associated with a low morbidity rate and helps in avoiding mechanical lithotripsy in 95.3% of cases for the endoscopic extraction of large or multiple common bile duct stones.