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

Boston Scientific Corporation70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Biliary Strictures Caused by Malignant Neoplasms

Interventions

WallFlex™ Biliary Partially-Covered StentDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

ULB Erasme Hospital

Brussels, Belgium

Hopital Edouard Herriot

Lyon, Cedex 3, France

EVK Krankenhaus der Universitat Dusseldorf

Düsseldorf, Germany

Asian Institute of Gastroenterology

Hyderabaad, India

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

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

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

Time frame: Initial stent placement procedure

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.

Time frame: Up to 6 months post-initial study treatment

Change in Biliary Obstruction Symptoms

Incidence of symptoms of biliary obstruction

Time frame: up to 6 months post-initial study treatment

Data from ClinicalTrials.gov

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