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)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- unresectable distal biliary malignancy
- Sponsor
- EWCOMER12 study group
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Patients with massive ascites 2\) Patients with serious problem in any other organs 3\) Patients whose stricture extends to hilar bile duct 4\) Patients with Inaccessible to the duodenal papilla (ex. total gastrectomy) 5\) Contraindications of endoscopic procedure 6\) Patients with intestinal obstruction in the distal to the ampulla
Outcomes
Primary Outcomes
Not specified