N/A
N=23
Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures
Benign Biliary Strictures
Bottom Line
View on ClinicalTrials.gov: NCT01238900 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Short Term Success Rate in the Resolution of Biliary Strictures — 22; 14; 3; 5 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Endoscopic Retrograde Cholangiopancreatography (ERCP) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Term Success Rate in the Resolution of Biliary Strictures |
22; 14; 3; 5 | — |
| PRIMARY Long-term Success Rate in Resolution of Biliary Strictures |
15; 8; 3; 4 | — |
| SECONDARY Number of Endoscopic Treatments Per Patient |
2.4 | — |
| SECONDARY Ease of Stent Removal |
21; 0; 2; 0 | — |
| SECONDARY Frequency and Severity of Adverse Events (Including Stent Migration) |
5; 1; 0; 0; 4 | — |
Summary
The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.
Eligibility Criteria
Inclusion Criteria
- Subject is 18 years or older
- Subject has benign biliary stricture
- Subject must be able to give informed consent
Exclusion Criteria
- Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
- The subject is unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT01238900). 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.