Clinical trial NCT00713427: Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Strictures Caused by Malignant Neoplasms
Keywords: Biliary
Strictures
Malignant
Neoplasm
Palliation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Absence of Recurrent Biliary Obstruction
timeFrame: Up to 6 months post treatment or prior to death, whichever came first
Secondary outcomes:
measure: Number of Adverse Events Related to the Device and/or Procedure
timeFrame: From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)
measure: Number of Participants With Technical Stent Placement Success
timeFrame: Initial stent placement procedure
measure: Number of Participants With Occurrence of Re-intervention
timeFrame: Up to 6 months post-initial study treatment
measure: Change in Biliary Obstruction Symptoms
timeFrame: up to 6 months post-initial study treatment
measure: Time to Recurrent Biliary Obstruction
timeFrame: Up to 6 months
measure: Change in Bilirubin
timeFrame: 1 month following stent placement
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB Erasme Hospital
city: Lyon
country: France
facility: Hopital Edouard Herriot
state: Cedex 3
city: Dusseldorf
country: Germany
facility: EVK Krankenhaus der Universitat Dusseldorf
city: Hyderabaad
country: India
facility: Asian Institute of Gastroenterology
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Universiteit van Amsterdam
state: AZ
Study officials:
affiliation: Boston Scientific Corporation
name: Robert Walsh, M.D.
role: STUDY_DIRECTOR
affiliation: Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
name: Guido Costamagna, M.D.
role: PRINCIPAL_INVESTIGATOR
References: