N/A
N=112
Covered Metallic Stents for First-Line Treatment of Benign Bile Duct Strictures
Common Bile Duct Stricture
Bottom Line
View on ClinicalTrials.gov: NCT01221311 ↗Enrolled (actual)
112
Serious AEs
20.5%
Results posted
May 2017
Primary outcome: Primary: Early Clinical Success — 50; 41 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fully covered Metallic Stent (Device); Plastic Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Clinical Success |
50; 41 | — |
Summary
The current standard of care for benign bile duct strictures involves placement of multiple plastic stents under endoscopic and fluoroscopic guidance to progressively dilate or stretch it open. This approach necessitates multiple procedures which may extend over one year before the stricture is adequately dilated. The investigators propose a study comparing the standard approach of plastic stenting with the use of newer, fully coated metallic stents which are self-expandable, thereby permitting successful dilation of benign bile duct strictures with fewer procedures.
Eligibility Criteria
Inclusion Criteria
- Bismuth Type I benign bile duct stricture
- Objective signs/symptoms related to the stricture
Exclusion Criteria
- Suspected malignant etiology for the stricture
- Prior endotherapy within one year of presentation,except in the following two scenarios: 1) Early ( 1cm below the cystic duct insertion
- Age 8cm in length
- Life expectancy < 1 year
- Concomitant nonanastomotic biliary strictures or biliary casts
Data sourced from ClinicalTrials.gov (NCT01221311). 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.