Clinical trial NCT00433771: A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Official title: A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cholestasis, Extrahepatic
Keywords: Malignant
Cholestasis, Extrahepatic
Biliary obstruction
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2007-02-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.


Eligibility criteria: 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

Primary outcomes:
measure: Adequate Clinical Palliation of the Biliary Obstruction
timeFrame: 6 months
Secondary outcomes:
measure: Technical Success
timeFrame: At treatment
measure: Ability to Successfully Remove a Stent Upon Removal Attempt
timeFrame: 6 months
measure: Re-interventions
timeFrame: Until 6 months or death
measure: Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms
timeFrame: 1 Month
measure: Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
timeFrame: 3 months
measure: Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
timeFrame: 6 months
measure: Bilirubin Level Reduction
timeFrame: 1 month
measure: Stent Patency at 1 Month
timeFrame: 1 month
measure: Stent Patency at 3 Months
timeFrame: 3 Months
measure: Stent Patency at 6 Months
timeFrame: 6 Months
measure: Time to Stent Occlusion
timeFrame: Until 6 Months or death
measure: Number of Device-Related Adverse Events
timeFrame: Until 6 months or death
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: Univ. of Colorado Health Sciences
state: Colorado
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Durham
country: United States
facility: Duke University Med Center
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: Univ. of VA Medical Center
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Seattle Main Clinic
state: Washington
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: Bret Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References: