N/A
N=70
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Biliary Strictures Caused by Malignant Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00713427 ↗Enrolled (actual)
70
Serious AEs
13.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Absence of Recurrent Biliary Obstruction — 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- WallFlex™ Biliary Partially-Covered Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Absence of Recurrent Biliary Obstruction |
62 | — |
| SECONDARY Number of Adverse Events Related to the Device and/or Procedure |
9 | — |
| SECONDARY Number of Participants With Technical Stent Placement Success |
68 | — |
| SECONDARY Number of Participants With Occurrence of Re-intervention |
6 | — |
| SECONDARY Change in Biliary Obstruction Symptoms |
.62 | — |
| SECONDARY Time to Recurrent Biliary Obstruction |
110 | — |
| SECONDARY Change in Bilirubin |
-1.9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00713427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.