High-grade malignant hilar biliary obstructions High grade malignant hilar biliary obstructions, Bilataral drainage
Conditions
Interventions
Two SEMS (Self Expandable Metallic Stent) group
Three SEMS (Self Expandable Metallic Stent) group
Sponsors
Matsumoto Kazuyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Unresectable malignant hilar biliary obstructions with Bismuth type IIIa or IV 2. Age over 18 3. Patient with fully informed consent
Exclusion criteria
Exclusion criteria: 1. Reconstructed bowel other than Billroth 1 2. Inferior border of the biliary stricture extends close to the duodenal papilla which required stenting across the papilla Vater. 3. Endoscopic drainage will be ineffective due to severely divided bile duct, or severe portal vein invasion due to multiple liver metastasis. . 4. Radical resection, radiation therapy, and proton/particle therapy will be planned 5. Patient with pregnant or possibly pregnant. 6. Patient who are not expected to live 1 month or longer 7. Patient judged by the investigator to be inappropriate to enroll.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| non-recurrent biliary obstruction (non-RBO) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical Success, Clinical Success, Time to RBO, Cause of RBO, Complications other than RBO, Duration of procedure, Time to RBO by EST, Overall Survival, Technical Success and Clinical Success at Re-intervention | — |
Contacts
Public ContactMatsumoto Kazuyuki
Okayama University Hospital
Outcome results
None listed