A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cholestasis, Extrahepatic	Device: WallFlex™ Biliary Fully Covered Metal Stent placement	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, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

Resource links provided by NLM:

MedlinePlus related topics: Palliative Care

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Adequate Clinical Palliation of the Biliary Obstruction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Technical Success [ Time Frame: At treatment ] [ Designated as safety issue: Yes ]
Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.
Ability to Successfully Remove a Stent Upon Removal Attempt [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.
Re-interventions [ Time Frame: Until 6 months or death ] [ Designated as safety issue: No ]
Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.
Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.
Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.
Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.
Bilirubin Level Reduction [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.
Stent Patency at 1 Month [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.
Stent Patency at 3 Months [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).
Stent Patency at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).
Time to Stent Occlusion [ Time Frame: Until 6 Months or death ] [ Designated as safety issue: No ]
Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.
Number of Device-Related Adverse Events [ Time Frame: Until 6 months or death ] [ Designated as safety issue: Yes ]
Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.

Enrollment:	74
Study Start Date:	March 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: WallFlex Biliary Fully Covered stent Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent	Device: WallFlex™ Biliary Fully Covered Metal Stent placement Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433771

Locations

United States, California
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Colorado
Univ. of Colorado Health Sciences
Aurora, Colorado, United States, 80010
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Med Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Univ. of VA Medical Center
Charlottesville, Virginia, United States, 800708
United States, Washington
Virginia Mason Seattle Main Clinic
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:

Bret Petersen, MD

Mayo Clinic, Rochester MN

More Information

No publications provided

Responsible Party:	Jeremy Bolt, Boston Scientific
ClinicalTrials.gov Identifier:	NCT00433771 History of Changes
Other Study ID Numbers:	ENDO-WALLFLEX-BIL-PALL-001U, E7009
Study First Received:	February 8, 2007
Results First Received:	September 25, 2009
Last Updated:	June 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Malignant
Cholestasis, Extrahepatic
Biliary obstruction

Additional relevant MeSH terms:

Cholestasis, Extrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013