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Completed

NCT Number: NCT00713427

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

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.

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Key information

Conditions

Biliary Strictures Caused by Malignant Neoplasms Constriction, Pathologic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ULB Erasme Hospital, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WallFlex™ Biliary Partially-Covered Stent

Device

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 outcomes

  1. Number of Participants With Absence of Recurrent Biliary Obstruction

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

    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 outcomes

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

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

    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.

  2. Number of Participants With Technical Stent Placement Success

    Time frame: Initial stent placement procedure

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

  3. Number of Participants With Occurrence of Re-intervention

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

    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.

  4. Change in Biliary Obstruction Symptoms

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

    Incidence of symptoms of biliary obstruction

  5. Time to Recurrent Biliary Obstruction

    Time frame: Up to 6 months

    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.

  6. Change in Bilirubin

    Time frame: 1 month following stent placement

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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2008
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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