A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12 - A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12 (NEWCOMER 12)

RESULTS: The technical and functional success rates of the procedures were 100%. The 6-month non-RBO rate was 50%, and the median time to RBO was 184 days. The median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with 7 experiencing stent occlusion and 3 experiencing stent migration. Adverse events other than RBO (at < 30 days) developed in 6 patients (16%; cholecystitis, 1; pancreatitis, 1; hyperamylasemia, 1; pancreatic ductitis, 1; abdominal pain, 2). Stent removal for reintervention was successfully completed in 8 patients. CONCLUSIONS: Our novel FCSEMS may be safe and effective for managing malignant distal obstructions with an acceptable incidence of adverse events.