BACKGROUND Although reports on endosonography-guided biliary drainage (ESBD) have been increasing, only a few discuss deployment of a self-expandable metal stent (SEMS) in the first session. OBJECTIVE To evaluate the safety and efficacy of ESBD with the one-step placement of a newly designed fully-covered SEMS. METHODS Five patients with malignant biliary obstruction in whom one-step placement of an anti-migration designed SEMS in the first session of ESBD had been attempted between January 2007 and October 2009 were included in this study. Main outcome measurements were technical and clinical successes, early complications, and short-term results. RESULTS ESBD was attempted to bridge the extrahepatic bile duct and the duodenum and one-step SEMS placement was successful in all cases. There were no early complications related to ESBD and excellent biliary decompression was obtained in all cases. SEMS dysfunction such as stent migration and occlusion was not seen during the follow-up period (mean follow-up 138 days, range 102-184 days). CONCLUSIONS One-step placement of a fully-covered SEMS in ESBD is possibly a safe and effective treatment for biliary obstruction.