N/A
Completed N=6
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Distal Bile Duct Obstruction
Source: ClinicalTrials.gov NCT01905384 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Rate of Long-term Stent Failure — 0; 2 Participants
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.
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 | — |
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. Informational only — not medical advice.