WallFlex Biliary Post Liver Transplant IDE Pilot
WallFlex Biliary Post Liver Transplant IDE Pilot
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary
 RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant
 (OLT) patients.
Inclusion Criteria:

 1. Age 18 or older

 2. Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic
 biliary stricture as assessed by:

 -  Clinical signs and symptoms including jaundice, abdominal pain, pruritis, and
 cholangitis

 -  Abnormal liver function tests (serum bilirubin > 1.5 and/or elevated alkaline
 phosphatase levels)

 -  Abnormal imaging on ultrasound, CT scan, or MRCP suggestive of a biliary
 stricture

 3. Willingness and ability to comply with the study procedures and provide written
 informed consent to participate in the study.

 Exclusion Criteria:

 1. Roux-en-Y choledochojejunostomy

 2. Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures,
 strictures that are longer than 8cm in length, strictures located in the intrahepatic
 ducts and/or in the donor duct proximal to the site of anastomosis)

 3. Living donor transplants

 4. Transplants performed within 30 days (fresh transplants)

 5. Perforation of any duct within the biliary tree

 6. Patients with known sensitivity to any components of the stent or delivery system

 7. Patients with malignancy involving the biliary tree (including hepatocellular
 carcinoma)

 8. Patients with poor Karnofsky score

 9. Life expectancy of less than one year

 10. Inability to pass a guidewire through the strictured area

 11. Previous biliary metal or multiple plastic stent placement

 12. Drug-induced or cholestatic hepatitis from an infective cause

 13. Redundant bile duct that may be treated by temporary placement of stent or conversion
 to a RouxEnY hepaticojejunostomy

 14. Choledocholithiasis/biliary "cast" syndrome