Status:
COMPLETED
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Distal Bile Duct Obstruction
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief 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 malign...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01905384
Start Date
November 8 2017
End Date
December 1 2020
Last Update
March 31 2022
Active Locations (2)
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1
Mount Sinai Hospital
New York, New York, United States, 10029
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212