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

A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

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.

Study Overview

• Status: Completed
• Conditions: Cholestasis, Extrahepatic
• Intervention / Treatment: Device: WallFlex™ Biliary Fully Covered Metal Stent placement

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Bret Petersen, MD, Mayo Clinic, Rochester, MN

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: February 8, 2007
• First Submitted That Met QC Criteria: February 8, 2007
• First Posted (Estimate): February 12, 2007

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 21, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Malignant; Cholestasis, Extrahepatic; Biliary obstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis; Cholestasis, Extrahepatic
• Other Study ID Numbers: ENDO-WALLFLEX-BIL-PALL-001U; E7009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No