BACKGROUND: Recently, endoscopic biliary sphincterotomy (EBS) followed by large-diameter balloon dilation has been used for the removal of large bile duct stones. A limitation is the need for 2 accessories: a sphincterotome and a dilating balloon. OBJECTIVE: To evaluate a new device, a combination of a large-diameter dilating balloon and sphincterotome (LDDBS). DESIGN: Retrospective study. SETTING: University hospital. PATIENTS: Eighteen patients with large bile duct stones. INTERVENTIONS: After performing EBS by using the LDDBS, the catheter was then advanced into the bile duct and balloon dilation was performed by gradual inflation with diluted contrast medium under endoscopic and fluoroscopic guidance until it reached a diameter adequate to allow stone removal. MAIN OUTCOME MEASUREMENTS: Feasibility and efficacy of stone removal by using an LDDBS. RESULTS: Technical success of large-diameter balloon dilation after EBS was achieved in all cases. Bile duct clearance was accomplished in 94% (17/18) of cases in the first session. Bile duct clearance was eventually completed in all patients. Mechanical lithotripsy was required in 4 patients (22%). There were no major intraprocedural or postprocedural complications. LIMITATIONS: Single-institution study, small sample size. CONCLUSIONS: The prototype LDDBS is safe and effective to facilitate the removal of large bile duct stones by using one accessory.
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