A pilot study of new covered metallic stent with large bore size for the unresectable distal biliary malignancies: Niti-S SUPREMO-12
- Conditions
- unresectable distal biliary malignancy
- Registration Number
- JPRN-UMIN000007061
- Lead Sponsor
- EWCOMER12 study group
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Stent occlusion rate and dysfunction rate 2) Stent patency duration 3) Time to dysfunction 4) Overall stent patency rate and function rate
- Secondary Outcome Measures
Name Time Method 1) Median survival time 2) Stent-related complication rate