N/A
N=6
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Distal Bile Duct Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT01905384 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Rate of Long-term Stent Failure — 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Covered Self-expanding metal biliary stents (C-SEMS) (Device); Uncovered Self-expanding metal biliary stents (U-SEMS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Long-term Stent Failure |
0; 2 | — |
| SECONDARY Rates of Adverse Stent-related or Intervention-related Outcomes |
0; 0 | — |
Summary
The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
Eligibility Criteria
Inclusion Criteria
- distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
- 18 years of age or older
- serum bilirubin > 2mg/dL
Exclusion Criteria
- prior endoscopic or percutaneous biliary drainage
- post-surgical anatomy
- primary site of biliary obstruction involving the common hepatic duct or hilum
- tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation
Data sourced from ClinicalTrials.gov (NCT01905384). 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.