Clinical trial NCT01151280: WallFlex Biliary Post Liver Transplant IDE Pilot
Official title: A Multi-Center, Prospective Study the WallFlex Biliary RX Fully Covered Stent for the Treatment of Anastomotic Biliary Strictures in Post Liver Transplant Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Stricture Resolution at the Time of Stent Removal.
timeFrame: At 3 months (per protocol removal) or at early removal.
Secondary outcomes:
measure: Safety
timeFrame: From enrollment through end of study.
measure: Stent Removability
timeFrame: At 3 months (per protocol removal) or early removal
measure: Technical Success of Stent Placement
timeFrame: At stent placement (Day 1)
measure: Effectiveness of Stent at 6 Months
timeFrame: From stent removal through 6 months post stent removal follow-up.
measure: Re-intervention Occurrence
timeFrame: 6 months post stent removal
measure: Time to Stent Occlusion
timeFrame: mean time from stent placement to stent removal for all 10 patients was 91.3 days.
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cleveland
country: United States
facility: Mansour Parsi, MD
state: Ohio
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Divyesh Sejpal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: