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

Cholestasis, Extrahepatic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433771
• Other study ID #: ENDO-WALLFLEX-BIL-PALL-001U
• Secondary ID: E7009
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2007
• Last updated: June 21, 2010
• Start date: March 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2010
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cholestasis
• Cholestasis, Extrahepatic

Intervention

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.

Locations

Country	Name	City	State
United States	Univ. of Colorado Health Sciences	Aurora	Colorado
United States	Univ. of VA Medical Center	Charlottesville	Virginia
United States	Duke University Med Center	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	California Pacific Medical Center	San Francisco	California
United States	Virginia Mason Seattle Main Clinic	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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.	At treatment	Yes
Secondary	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.	6 months	No
Secondary	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.	Until 6 months or death	No
Secondary	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.	1 Month	No
Secondary	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.	3 months	No
Secondary	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.	6 months	No
Secondary	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.	1 month	No
Secondary	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.	1 month	No
Secondary	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).	3 Months	No
Secondary	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).	6 Months	No
Secondary	Time to Stent Occlusion	Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.	Until 6 Months or death	No
Secondary	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.	Until 6 months or death	Yes