Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
- Conditions
- Biliary Strictures Caused by Malignant Neoplasms
- Interventions
- Device: WallFlex™ Biliary Partially-Covered Stent
- Registration Number
- NCT00713427
- Lead Sponsor
- Boston Scientific Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WallFlex Stent WallFlex™ Biliary Partially-Covered Stent 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Absence of Recurrent Biliary Obstruction 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 Outcome Measures
Name Time Method Change in Biliary Obstruction Symptoms up to 6 months post-initial study treatment Incidence of symptoms of biliary obstruction
Time to Recurrent Biliary Obstruction 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.
Change in Bilirubin 1 month following stent placement Bilirubin change at 1 month following stent placement as assessed against bilirubin at baseline.
Number of Participants With Technical Stent Placement Success Initial stent placement procedure 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 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.
Number of Adverse Events Related to the Device and/or Procedure 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.
Trial Locations
- Locations (6)
ULB Erasme Hospital
🇧🇪Brussels, Belgium
EVK Krankenhaus der Universitat Dusseldorf
🇩🇪Dusseldorf, Germany
Asian Institute of Gastroenterology
🇮🇳Hyderabaad, India
Academisch Medisch Centrum Universiteit van Amsterdam
🇳🇱Amsterdam, AZ, Netherlands
Hopital Edouard Herriot
🇫🇷Lyon, Cedex 3, France
Università Cattolica del Sacro Cuore
🇮🇹Rome, Italy