Malignant biliary obstruction malignant obstruction of the biliary tract
Conditions
Interventions
Patients will be treated with a WallFlex Biliary Partially-covered stent.
Sponsors
Boston Scientific Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inoperable extrahepatic biliary obstruction by any malignant process. Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms.
Exclusion criteria
Exclusion criteria: Strictures that cannot be dilated enough to pass the delivery system. Perforation of any duct within the biliary tree. Presence of metal biliary stent. Patients with active hepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate clinical palliation of the biliary obstruction defined as absence of recurrent biliary obstruction within 6 months or prior to death, whichever comes first. Recurrent biliary obstruction will be determined by the treating physician based on imaging of the stent and/or cholestatic symptoms and/or abnormal liver function tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety 2. Technical success of stent placement 3. Re-interventions 4. Clinical symptoms of biliary obstruction 5. Laboratory liver tests 6. Recurrent biliary obstructions at 1 week, 2 weeks, 1 month, 3 months and 6 months 7. Time to recurrent biliary obstruction 8. The possibility of stent removal during placement | — |
Countries
Netherlands
Outcome results
None listed