Phase 3
N=74
A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
Cholestasis, Extrahepatic
Bottom Line
View on ClinicalTrials.gov: NCT00433771 ↗Enrolled (actual)
74
Serious AEs
77.6%
Results posted
Feb 2010
Primary outcome: Primary: Adequate Clinical Palliation of the Biliary Obstruction — 54 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- WallFlex™ Biliary Fully Covered Metal Stent placement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adequate Clinical Palliation of the Biliary Obstruction |
54 | — |
| SECONDARY Technical Success |
57 | — |
| SECONDARY Ability to Successfully Remove a Stent Upon Removal Attempt |
2 | — |
| SECONDARY Re-interventions |
1 | — |
| SECONDARY Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms |
45 | — |
| SECONDARY Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms |
33 | — |
| SECONDARY Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms |
23 | — |
| SECONDARY Bilirubin Level Reduction |
44 | — |
| SECONDARY Stent Patency at 1 Month |
44 | — |
| SECONDARY Stent Patency at 3 Months |
31 | — |
| SECONDARY Stent Patency at 6 Months |
21 | — |
| SECONDARY Time to Stent Occlusion |
142 | — |
| SECONDARY Number of Device-Related Adverse Events |
6 | — |
Summary
The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- Clinical symptoms of biliary obstruction
- Inoperable extrahepatic biliary obstruction by any malignant process
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion Criteria
- Participation in an Investigational Study within 90 days prior to date of patient consent
- Strictures that cannot be dilated enough to pass the delivery system
- Perforation of any duct within the biliary tree
- Presence of a metal biliary stent
- Presence of any esophageal or duodenal stent
- Patients for whom endoscopic procedures are contraindicated
- Patients with known sensitivity to any components of the stent or delivery system
- Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
- Patients with an anticipated life expectancy of < 3 months
Data sourced from ClinicalTrials.gov (NCT00433771). 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.