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A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction


Phase 3
18 Years
N/A
Not Enrolling
Both
Cholestasis, Extrahepatic

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Trial Information

A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction


Inclusion Criteria:



- Age 18 or older

- Clinical symptoms of biliary obstruction

- Inoperable extrahepatic biliary obstruction by any malignant process

- Willing and able to comply with the study procedures and provide written informed
consent to participate in the study.

Exclusion Criteria:

- Participation in an Investigational Study within 90 days prior to date of patient
consent

- Strictures that cannot be dilated enough to pass the delivery system

- Perforation of any duct within the biliary tree

- Presence of a metal biliary stent

- Presence of any esophageal or duodenal stent

- Patients for whom endoscopic procedures are contraindicated

- Patients with known sensitivity to any components of the stent or delivery system

- Patients with active hepatitis or intrahepatic metastases that extensively involves
both lobes of the liver

- Patients with an anticipated life expectancy of < 3 months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adequate Clinical Palliation of the Biliary Obstruction

Outcome Description:

Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Bret Petersen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic, Rochester MN

Authority:

United States: Food and Drug Administration

Study ID:

ENDO-WALLFLEX-BIL-PALL-001U

NCT ID:

NCT00433771

Start Date:

March 2007

Completion Date:

May 2008

Related Keywords:

  • Cholestasis, Extrahepatic
  • Malignant
  • Cholestasis, Extrahepatic
  • Biliary obstruction
  • Cholestasis, Extrahepatic
  • Cholestasis

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Mayo ClinicRochester, Minnesota  55905
Washington University School of MedicineSaint Louis, Missouri  63110
Hennepin County Medical CenterMinneapolis, Minnesota  
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
California Pacific Medical CenterSan Francisco, California  94115
Univ. of Colorado Health SciencesAurora, Colorado  80010
Duke University Med CenterDurham, North Carolina  27710
Univ. of VA Medical CenterCharlottesville, Virginia  800708
Virginia Mason Seattle Main ClinicSeattle, Washington  98101