WallFlex Biliary Fully Covered (FC) Benign Stricture Study
Condition: Biliary Stricture
MeSH terms: Cholestasis; Constriction, Pathologic
Intervention: WallFlex Biliary RX Fully Covered Stent System
Intervention description: Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant

Summary:

      The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary
      RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct
      strictures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Willing and able to comply with the study procedures and provide written informed
             consent to participate in the study

          -  Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery
             (to include cholecystectomy)

          -  Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture
             (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by
             cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of
             prior plastic stent(s) for management of benign stricture

        Exclusion Criteria:

        General:

          -  Placement of the stent in strictures that cannot be dilated enough to pass the
             delivery system

          -  Placement of the stent in a perforated duct

          -  Placement of the stent in very small intrahepatic ducts

          -  Patients for whom endoscopic techniques are contraindicated

          -  Biliary stricture of malignant etiology

          -  Biliary stricture of benign etiology other than chronic pancreatitis or liver
             transplant anastomosis or other abdominal surgery

          -  Stricture within 2 cm of duct bifurcation

          -  Symptomatic duodenal stenosis (with gastric stasis)

          -  Prior biliary self-expanding metal stent

          -  Suspected stricture ischemia based on imaging of hepatic artery occlusion or
             endoscopic evidence of biliary cast syndrome

          -  Known bile duct fistula

          -  Known sensitivity to any components of the stent or delivery system

          -  Participation in another investigational study within 90 days prior to consent or
             during the study

        Additional Specific to Chronic Pancreatitis Patients:

          -  Developing obstructive biliary symptoms associated with an attack of acute
             pancreatitis

        Additional Specific to Post-Abdominal Surgery Patients:

          -  History of hepatectomy

          -  History of liver transplant

        Additional Specific to Liver Transplant Patients:

          -  Live donor transplantation