unresectable distal malignant biliary stenosis
Conditions
Interventions
6mm diameter FCSEMS+PS group and 10mm diameter FCSEMS group
Sponsors
Matsumoto Kazuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with unresectable distal malignant biliary stenosis 2. Age over 18 3. Patient with fully informed consent
Exclusion criteria
Exclusion criteria: 1. Patient with hilar biliary stenosis(distance from the hilar bile duct to the stenosis is less than 2 cm) 2. Radical resection, radiation therapy, and proton/particle therapy will be planned 3. Patient with uncontrolable cholangitis 4. Reconstructed bowel other than Billroth 1 5. Patient who are not expected to live 3 month or longer 6. ASA-PS 4-5 7. Patient with pregnant or possibly pregnant 8. Patient judged by the investigator to be inappropriate to enroll
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free rate up to 180 days after stent placement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Technical Success 2. Clinical Success 3. TRBO(time to RBO) 4. non RBO ratio 5. Causes of RBO 6. Complications other than RBO 7. Event-free survival rate up to 180 days after stent placement 8. Duration of procedure 9. Overall Survival | — |
Contacts
Public ContactKentaro Oki
Okayama university
Outcome results
None listed