Trial Information
A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Inclusion Criteria:
- Age 18 years or older
- Inoperable extrahepatic biliary obstruction by any malignant process
- Indicated for metal stent placement for palliative treatment of biliary stricture(s)
produced by malignant neoplasms
- Willing and able to comply with the study procedures and provide written informed
consent to participate in the study
Exclusion Criteria:
- Participation in another invesitgational study within 90 days prior to date of
patient consent.
- Strictures that cannot be dialated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence of any esophageal or duodenal stent
- Patients for whom endoscopic procedures are contraindicated
- Patients with known senesitivity to any components of the stent or delivery system
- Patients with active hepatitis
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary outcome measured will be the adequate clinical palliation of the biliary obstruction defined as absence of recurrent biliary obstruction. Recurrent biliary obstruction will be determined by treating physicians.
Outcome Time Frame:
6 months or death, whichever comes first
Safety Issue:
Yes
Principal Investigator
Robert Walsh, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
Boston Scientific Corporation
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
ENDO-WALLFLEX-BIL-PALL-002
NCT ID:
NCT00713427
Start Date:
July 2007
Completion Date:
May 2008
Related Keywords:
- Biliary Strictures Caused by Malignant Neoplasms
- Biliary
- Strictures
- Malignant
- Neoplasm
- Palliation
- Neoplasms
- Cholestasis
- Constriction, Pathologic