N/A
N=23
Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction
Biliary Stricture
Bottom Line
View on ClinicalTrials.gov: NCT03115411 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Count of Participants With Stent Patency at 90 Days — 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Winged biliary stent (ViaDuct™) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Stent Patency at 90 Days |
22 | — |
Summary
Evaluation of ERCP with placement of a winged plastic biliary stent without a lumen for management of benign biliary strictures.
Eligibility Criteria
Inclusion Criteria
- All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
- Expected patient survival of at least 90 days
- High likelihood of patient follow-up
- Patient is able to give a written informed consent
- Patient is willing and able to comply with the study procedures.
Exclusion Criteria
- Patients with cholangitis
- Patients with bile leak
- Pregnant patients
- Patients with any contraindication to endoscopic procedure
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- Patients with malignant biliary strictures
Data sourced from ClinicalTrials.gov (NCT03115411). 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.