Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00713427
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : September 1, 2009
Information provided by:
Boston Scientific Corporation

Brief Summary:
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary Partially Covered Stent as a Palliative treatment for malignant bile duct obstruction.

Condition or disease Intervention/treatment Phase
Biliary Strictures Caused by Malignant Neoplasms Device: WallFlex™ Biliary Partially-Covered Stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Study Start Date : July 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
WallFlex Stent
All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.
Device: WallFlex™ Biliary Partially-Covered Stent
Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.

Primary Outcome Measures :
  1. The primary outcome measured will be the adequate clinical palliation of the biliary obstruction defined as absence of recurrent biliary obstruction. Recurrent biliary obstruction will be determined by treating physicians. [ Time Frame: 6 months or death, whichever comes first ]

Secondary Outcome Measures :
  1. Secondary outcome measures include the occurrence, severity, device- and procedure-relatedness of adverse events, device deployability and removability, re-interventions, biliary obstruction symptoms, liver function, and recurrent biliary obstruction. [ Time Frame: 6 months or death, whichever comes first ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18 years or older
  • Inoperable extrahepatic biliary obstruction by any malignant process
  • Indicated for metal stent placement for palliative treatment of biliary stricture(s) produced by malignant neoplasms
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

  • Participation in another invesitgational study within 90 days prior to date of patient consent.
  • Strictures that cannot be dialated enough to pass the delivery system
  • Perforation of any duct within the biliary tree
  • Presence of any esophageal or duodenal stent
  • Patients for whom endoscopic procedures are contraindicated
  • Patients with known senesitivity to any components of the stent or delivery system
  • Patients with active hepatitis

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 identifier (NCT number): NCT00713427

ULB Erasme Hospital
Brussels, Belgium, 1070
Hopital Edouard Herriot
Lyon, Cedex 3, France, 69437
EVK Krankenhaus der Universitat Dusseldorf
Dusseldorf, Germany, D-40217
Asian Institute of Gastroenterology
Hyderabaad, India, 500082
Università Cattolica del Sacro Cuore
Rome, Italy, 00168
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, AZ, Netherlands, 1105
Sponsors and Collaborators
Boston Scientific Corporation
Study Director: Robert Walsh, M.D. Boston Scientific Corporation
Principal Investigator: Guido Costamagna, M.D. Università Cattolica del Sacro Cuore, Policlinico A. Gemelli

Responsible Party: Jeremy Bolt, Boston Scientific Identifier: NCT00713427     History of Changes
Other Study ID Numbers: ENDO-WALLFLEX-BIL-PALL-002
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: September 1, 2009
Last Verified: August 2009

Keywords provided by Boston Scientific Corporation:

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