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WallFlex Biliary Post Liver Transplant IDE Pilot

Primary Purpose

Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WallFlex Biliary Fully Covered Stent
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Medical Center
  • Mansour Parsi, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WallFlex Biliary Fully Covered Stent

Arm Description

All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent

Outcomes

Primary Outcome Measures

Stricture Resolution at the Time of Stent Removal.
Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.

Secondary Outcome Measures

Safety
Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal. Unit of measure will be the actual number of adverse events that occurred.
Stent Removability
Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.
Technical Success of Stent Placement
Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.
Effectiveness of Stent at 6 Months
Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram. "Effectiveness" is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent. Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms.
Re-intervention Occurrence
Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.
Time to Stent Occlusion
Evidence of stent occlusion "stent occlusion" was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data.

Full Information

First Posted
June 21, 2010
Last Updated
November 27, 2013
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01151280
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WallFlex Biliary Fully Covered Stent
Arm Type
Experimental
Arm Description
All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent
Intervention Type
Device
Intervention Name(s)
WallFlex Biliary Fully Covered Stent
Intervention Description
Investigational device evaluated for the treatment for benign biliary strictures
Primary Outcome Measure Information:
Title
Stricture Resolution at the Time of Stent Removal.
Description
Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.
Time Frame
At 3 months (per protocol removal) or at early removal.
Secondary Outcome Measure Information:
Title
Safety
Description
Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal. Unit of measure will be the actual number of adverse events that occurred.
Time Frame
From enrollment through end of study.
Title
Stent Removability
Description
Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.
Time Frame
At 3 months (per protocol removal) or early removal
Title
Technical Success of Stent Placement
Description
Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.
Time Frame
At stent placement (Day 1)
Title
Effectiveness of Stent at 6 Months
Description
Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram. "Effectiveness" is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent. Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms.
Time Frame
From stent removal through 6 months post stent removal follow-up.
Title
Re-intervention Occurrence
Description
Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.
Time Frame
6 months post stent removal
Title
Time to Stent Occlusion
Description
Evidence of stent occlusion "stent occlusion" was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data.
Time Frame
mean time from stent placement to stent removal for all 10 patients was 91.3 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Divyesh Sejpal, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Mansour Parsi, MD
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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WallFlex Biliary Post Liver Transplant IDE Pilot

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