WallFlex Biliary Post Liver Transplant IDE Pilot

Completed · Not applicable

Conditions studied: Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

In brief

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.

Key facts

Study ID

NCT01151280

Run by

Boston Scientific Corporation

People needed

10

Starts

2009-10-01

Expected to finish

2012-12-01

Last updated by the study team

2013-12-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• 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
• Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.

You may not qualify if…

• Roux-en-Y choledochojejunostomy
• 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)
• Living donor transplants
• Transplants performed within 30 days (fresh transplants)
• Perforation of any duct within the biliary tree
• Patients with known sensitivity to any components of the stent or delivery system
• Patients with malignancy involving the biliary tree (including hepatocellular carcinoma)
• Patients with poor Karnofsky score
• Life expectancy of less than one year
• Inability to pass a guidewire through the strictured area
• Previous biliary metal or multiple plastic stent placement
• Drug-induced or cholestatic hepatitis from an infective cause
• Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy
• Choledocholithiasis/biliary "cast" syndrome

Where it is running

• Mount Sinai Medical Center — New York, New York, United States
• Mansour Parsi, MD — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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