Patients with unresectable malignant distal biliary obstruction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. unresectable malignant distal biliary obstruction without prior drainage 2. Age >= 20 y.o. 3. Serum T.Bil >=2.0 mg/dL 4. ECOG Performance Status 0-2 5. Informed consent
Exclusion criteria
Exclusion criteria: 1. Ascites 2. Prior gastric surgery 3. Biliary obstruction within 2 cm from hepatic hilum 4. Failure to detect CBD on EUS 5. Patients on anticoagulant or antiplatelet medications 6. Coagulopathy (Platlet < 50,000 or PT-INR >=2) 7. Severe comorbidity 8. Failed informed consent 9. Patients considered to be inadequate for clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Techinical success | — |
Secondary
| Measure | Time frame |
|---|---|
| complications, stent patency | — |
Countries
Japan
Contacts
The University of Tokyo Department of Gastroenterology, Graduate School of Medicine