A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Inclusion Criteria: * Age 18 or older * Clinical symptoms of biliary obstruction * Inoperable extrahepatic biliary obstruction by any malignant process * Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: * Participation in an Investigational Study within 90 days prior to date of patient consent * Strictures that cannot be dilated enough to pass the delivery system * Perforation of any duct within the biliary tree * Presence of a metal biliary stent * Presence of any esophageal or duodenal stent * Patients for whom endoscopic procedures are contraindicated * Patients with known sensitivity to any components of the stent or delivery system * Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver * Patients with an anticipated life expectancy of \< 3 months