Status:
COMPLETED
WallFlex Biliary Post Liver Transplant IDE Pilot
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01151280
Start Date
October 1 2009
End Date
December 1 2012
Last Update
December 25 2013
Active Locations (2)
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1
Mount Sinai Medical Center
New York, New York, United States, 10017
2
Mansour Parsi, MD
Cleveland, Ohio, United States, 44195