search
Back to results

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

Primary Purpose

Cholestasis, Extrahepatic

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
WallFlex™ Biliary Fully Covered Metal Stent placement
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis, Extrahepatic focused on measuring Malignant, Cholestasis, Extrahepatic, Biliary obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Pacific Medical Center
  • Univ. of Colorado Health Sciences
  • Hennepin County Medical Center
  • Mayo Clinic
  • Washington University School of Medicine
  • Duke University Med Center
  • Thomas Jefferson University
  • MD Anderson Cancer Center
  • Univ. of VA Medical Center
  • Virginia Mason Seattle Main Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WallFlex Biliary Fully Covered stent

Arm Description

Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent

Outcomes

Primary Outcome Measures

Adequate Clinical Palliation of the Biliary Obstruction
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
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
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
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
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
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
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
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
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
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
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 to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.
Number of Device-Related Adverse Events
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.

Full Information

First Posted
February 8, 2007
Last Updated
June 21, 2010
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00433771
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis, Extrahepatic
Keywords
Malignant, Cholestasis, Extrahepatic, Biliary obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WallFlex Biliary Fully Covered stent
Arm Type
Experimental
Arm Description
Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Intervention Type
Device
Intervention Name(s)
WallFlex™ Biliary Fully Covered Metal Stent placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adequate Clinical Palliation of the Biliary Obstruction
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Technical Success
Description
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.
Time Frame
At treatment
Title
Ability to Successfully Remove a Stent Upon Removal Attempt
Description
The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.
Time Frame
6 months
Title
Re-interventions
Description
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.
Time Frame
Until 6 months or death
Title
Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms
Description
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.
Time Frame
1 Month
Title
Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Description
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.
Time Frame
3 months
Title
Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Description
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.
Time Frame
6 months
Title
Bilirubin Level Reduction
Description
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.
Time Frame
1 month
Title
Stent Patency at 1 Month
Description
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.
Time Frame
1 month
Title
Stent Patency at 3 Months
Description
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).
Time Frame
3 Months
Title
Stent Patency at 6 Months
Description
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 Frame
6 Months
Title
Time to Stent Occlusion
Description
Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.
Time Frame
Until 6 Months or death
Title
Number of Device-Related Adverse Events
Description
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.
Time Frame
Until 6 months or death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret Petersen, MD
Organizational Affiliation
Mayo Clinic, Rochester, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Univ. of Colorado Health Sciences
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University Med Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ. of VA Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
800708
Country
United States
Facility Name
Virginia Mason Seattle Main Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs