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

Primary Purpose

Biliary Strictures Caused by Malignant Neoplasms

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

WallFlex™ Biliary Partially-Covered Stent

About this trial

This is an interventional treatment trial for Biliary Strictures Caused by Malignant Neoplasms focused on measuring Biliary, Strictures, Malignant, Neoplasm, Palliation

Eligibility Criteria

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

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

Sites / Locations

ULB Erasme Hospital
Hopital Edouard Herriot
EVK Krankenhaus der Universitat Dusseldorf
Asian Institute of Gastroenterology
Università Cattolica del Sacro Cuore
Academisch Medisch Centrum Universiteit van Amsterdam

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

WallFlex Stent

Arm Description

All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.

Outcomes

Primary Outcome Measures

Number of Participants With Absence of Recurrent Biliary Obstruction

Defined as absence of recurrent biliary obstruction defined as absence of biliary symptoms. Biliary symptoms, included, but were not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. Symptom assessment occurred during the Screening/Baseline period and at all follow-up time points.

Secondary Outcome Measures

Number of Adverse Events Related to the Device and/or Procedure

Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints.

Number of Participants With Technical Stent Placement Success

Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture

Number of Participants With Occurrence of Re-intervention

A re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial study stent. Re-intervention does not include a second WallFlex stent placement during the 7 days post initial placement as a second stent could have been placed due to misplacement or failure to cover the entire stricture.

Change in Biliary Obstruction Symptoms

Incidence of symptoms of biliary obstruction

Time to Recurrent Biliary Obstruction

Biliary obstruction symptoms were collected at all follow-up visits post treatment and included but not limited to jaundice, itching, right upper quadrant abdominal pain, nausea, vomiting, fever, and dark urine. The time to recurrent biliary obstruction was recorded.

Change in Bilirubin

Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.

Full Information

NCT ID

NCT00713427

First Posted

July 9, 2008

Last Updated

July 15, 2021

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00713427

Brief Title

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

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Strictures Caused by Malignant Neoplasms

Keywords

Biliary, Strictures, Malignant, Neoplasm, Palliation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WallFlex Stent

Arm Type

Other

Arm Description

All patients meeting eligibility criteria recieve the WallFlex™ Biliary Partially-Covered Stent, which has regulatory clearance in the areas in which the study is being conducted.

Intervention Type

Device

Intervention Name(s)

WallFlex™ Biliary Partially-Covered Stent

Intervention Description

Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is partially covered with a polymer to reduce the potential for tumor ingrowth through the stent.

Primary Outcome Measure Information:

Title

Number of Participants With Absence of Recurrent Biliary Obstruction

Description

Time Frame

Up to 6 months post treatment or prior to death, whichever came first

Secondary Outcome Measure Information:

Title

Number of Adverse Events Related to the Device and/or Procedure

Description

Number of adverse events (serious and non-serious) related to the device and/or procedure were collected following informed consent, treatment, and at all follow-up timepoints.

Time Frame

From time participant signs informed consent until time participant exits study (up to 6 months following stent placement)

Title

Number of Participants With Technical Stent Placement Success

Description

Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture

Time Frame

Initial stent placement procedure

Title

Number of Participants With Occurrence of Re-intervention

Description

Time Frame

Up to 6 months post-initial study treatment

Title

Change in Biliary Obstruction Symptoms

Description

Incidence of symptoms of biliary obstruction

Time Frame

up to 6 months post-initial study treatment

Title

Time to Recurrent Biliary Obstruction

Description

Time Frame

Up to 6 months

Title

Change in Bilirubin

Description

Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.

Time Frame

1 month following stent placement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Walsh, M.D.

Organizational Affiliation

Boston Scientific Corporation

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Guido Costamagna, M.D.

Organizational Affiliation

Università Cattolica del Sacro Cuore, Policlinico A. Gemelli

Official's Role

Principal Investigator

Facility Information:

Facility Name

ULB Erasme Hospital

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Hopital Edouard Herriot

City

Lyon

State/Province

Cedex 3

ZIP/Postal Code

69437

Country

France

Facility Name

EVK Krankenhaus der Universitat Dusseldorf

City

Dusseldorf

ZIP/Postal Code

D-40217

Country

Germany

Facility Name

Asian Institute of Gastroenterology

City

Hyderabaad

ZIP/Postal Code

500082

Country

India

Facility Name

Università Cattolica del Sacro Cuore

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

Academisch Medisch Centrum Universiteit van Amsterdam

City

Amsterdam

State/Province

ZIP/Postal Code

1105

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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