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WallFlex Biliary Post Liver Transplant IDE Pilot

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ClinicalTrials.gov Identifier: NCT01151280
Recruitment Status : Completed
First Posted : June 28, 2010
Results First Posted : July 19, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Anastomotic Biliary Stricture Post Orthotopic Liver Transplant Device: WallFlex Biliary Fully Covered Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: WallFlex Biliary Fully Covered Stent
All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent
Device: WallFlex Biliary Fully Covered Stent
Investigational device evaluated for the treatment for benign biliary strictures




Primary Outcome Measures :
  1. Stricture Resolution at the Time of Stent Removal. [ Time Frame: At 3 months (per protocol removal) or at early 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 :
  1. Safety [ Time Frame: From enrollment through end of study. ]

    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.


  2. Stent Removability [ Time Frame: At 3 months (per protocol removal) or early removal ]
    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.

  3. Technical Success of Stent Placement [ Time Frame: At stent placement (Day 1) ]
    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.

  4. Effectiveness of Stent at 6 Months [ Time Frame: From stent removal through 6 months post stent removal follow-up. ]

    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.


  5. Re-intervention Occurrence [ Time Frame: 6 months post stent removal ]
    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.

  6. Time to Stent Occlusion [ Time Frame: mean time from stent placement to stent removal for all 10 patients was 91.3 days. ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151280


Locations
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United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10017
United States, Ohio
Mansour Parsi, MD
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Divyesh Sejpal, M.D. Icahn School of Medicine at Mount Sinai

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01151280     History of Changes
Other Study ID Numbers: E7055
E7055 ( Other Identifier: Boston Scientific )
First Posted: June 28, 2010    Key Record Dates
Results First Posted: July 19, 2013
Last Update Posted: December 25, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Constriction, Pathologic
Cholestasis
Pathological Conditions, Anatomical
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases