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WallFlex Biliary Fully Covered (FC) Benign Stricture Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01014390
First received: November 13, 2009
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct strictures.


Condition Intervention Phase
Biliary Stricture
 Device: WallFlex Biliary RX Fully Covered Stent System
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective Study of the WallFlex Biliary RX Fully Covered Stent for the Treatment of Benign Biliary Strictures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Stent Removability, defined as ability to remove the stent endoscopically without serious stent-removal related adverse events as assessed from the time of stent removal to 1 month post-stent removal. [ Time Frame: Time from stent removal to 1 month post-stent removal ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stricture resolution during stent indwell, defined by lack of stent-related re-interventions [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Stricture resolution after stent removal, defined by lack of stricture-related re-intervention [ Time Frame: Up to 60 months after stent removal ] [ Designated as safety issue: No ]
  • Occurrence and severity of adverse events related to the stent and/or the procedure [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]
  • Ability to deploy the stent in satisfactory position across the stricture (technical success at placement) [ Time Frame: Stent placement procedure ] [ Designated as safety issue: No ]
  • Length of stent placement procedure, length of stent removal procedure and methods of removal (to include video recording if available) [ Time Frame: Stent placement through removal ] [ Designated as safety issue: No ]
  • Biliary obstructive symptom assessment at all visits: Right Upper Quadrant Pain, Fever/Chills, Jaundice, Itching, Dark urine, Pale stools, Nausea/Vomiting [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • Liver Function Tests (LFT's) at baseline, at month 1 post-stent placement, at stent removal and at months 6, 12 and 24 post-stent removal [ Time Frame: Up to 24 months post-stent removal ] [ Designated as safety issue: No ]

Estimated Enrollment: 187
Study Start Date: December 2009
Estimated Study Completion Date: November 2017
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WallFlex Biliary RX FC Stent System
The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.
 Device: WallFlex Biliary RX Fully Covered Stent System
Temporary placement of a biliary stent as a treatment of biliary obstruction resulting from benign bile duct strictures. The stent is fully covered with a silicone polymer to reduce the potential of tissue ingrowth into the stent. The stent is removed after 5 months (±1 month) after stent placement in Post-Liver Transplant patients and after 11 months (±1 month) in Chronic Pancreatitis and Post-Abdominal Surgery patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study
  • Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery (to include cholecystectomy)
  • Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of prior plastic stent(s) for management of benign stricture

Exclusion Criteria:

General:

  • Placement of the stent in strictures that cannot be dilated enough to pass the delivery system
  • Placement of the stent in a perforated duct
  • Placement of the stent in very small intrahepatic ducts
  • Patients for whom endoscopic techniques are contraindicated
  • Biliary stricture of malignant etiology
  • Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery
  • Stricture within 2 cm of duct bifurcation
  • Symptomatic duodenal stenosis (with gastric stasis)
  • Prior biliary self-expanding metal stent
  • Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome
  • Known bile duct fistula
  • Known sensitivity to any components of the stent or delivery system
  • Participation in another investigational study within 90 days prior to consent or during the study

Additional Specific to Chronic Pancreatitis Patients:

  • Developing obstructive biliary symptoms associated with an attack of acute pancreatitis

Additional Specific to Post-Abdominal Surgery Patients:

  • History of hepatectomy
  • History of liver transplant

Additional Specific to Liver Transplant Patients:

  • Live donor transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014390

Locations
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Austria
Medical University of Vienna
Vienna, Austria
Belgium
ULB Erasme Hospital
Brussels, Belgium
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada
Canada, Quebec
MUHC - McGill University
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal-Saint-Luc Hospital
Montreal, Quebec, Canada, H2X 3J4
Chile
Clinica Alemana de Santiago
Santiago, Chile
France
Hopital Edouard Herriot
Lyon, France
Germany
Evangelischen Krankenhaus
Dusseldorf, Germany
India
Asian Institute of Gastroenterology
Hyderabad, India
Italy
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Rome, Italy, 00168
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Spain
Hospital Universitari Doctor Josep Trueta
Girona, Catalunya, Spain
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01014390     History of Changes
Other Study ID Numbers: CDM 00027550
Study First Received: November 13, 2009
Last Updated: April 26, 2013
Health Authority: Austria: Agency for Health and Food Safety
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Italy: Ministry of Health
Netherlands: Dutch Health Care Inspectorate
Spain: Spanish Agency of Medicines

Keywords provided by Boston Scientific Corporation:
benign biliary strictures secondary to chronic pancreatitis/post abdominal surgery/post liver transplant

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

ClinicalTrials.gov processed this record on June 18, 2013