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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

Tracking Information
First Submitted Date  ICMJE June 21, 2010
First Posted Date  ICMJE June 28, 2010
Results First Submitted Date  ICMJE April 12, 2013
Results First Posted Date  ICMJE July 19, 2013
Last Update Posted Date December 25, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Feasibility and Effectiveness of the WallFlex Biliary RX Fully Covered Stent for treatment of anastomotic biliary strictures in post-OLT patients [ Time Frame: At 3 months ]
Effectiveness is measured by assessing the resolution of the stricture at the time of stent removal
Change History Complete list of historical versions of study NCT01151280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2013)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
  • Safety [ Time Frame: Up to 6 months ]
    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.
  • Stent Removability [ Time Frame: At 3 months ]
    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 [ 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.
  • Effectiveness of Stent at 6 Months [ Time Frame: At 6 months ]
    Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram
  • 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.
  • Time to Stent Occlusion [ Time Frame: Up to 6 months ]
    Evidence of stent occlusion
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE WallFlex Biliary Post Liver Transplant IDE Pilot
Official Title  ICMJE A Multi-Center, Prospective Study the WallFlex Biliary RX Fully Covered Stent for the Treatment of Anastomotic Biliary Strictures in Post Liver Transplant Patients.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
Intervention  ICMJE Device: WallFlex Biliary Fully Covered Stent
Investigational device evaluated for the treatment for benign biliary strictures
Study Arms  ICMJE Experimental: WallFlex Biliary Fully Covered Stent
All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent
Intervention: Device: WallFlex Biliary Fully Covered Stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2010)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2010)
58
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01151280
Other Study ID Numbers  ICMJE E7055
E7055 ( Other Identifier: Boston Scientific )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Divyesh Sejpal, M.D. Icahn School of Medicine at Mount Sinai
PRS Account Boston Scientific Corporation
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP