Status:
UNKNOWN
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction
Lead Sponsor:
Samsung Medical Center
Conditions:
Biliary Tract Neoplasms
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.
Detailed Description
Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive ...
Eligibility Criteria
Inclusion
- \> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
Exclusion
- history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR\>1.5, Platelet\<50000) 4.expected survival \> 3 months based on Karnofsky performance score 5.duodenal stricture
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02255669
Start Date
October 1 2014
End Date
October 1 2016
Last Update
February 12 2015
Active Locations (1)
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1
Samsung Medical Cencer
Seoul, South Korea, 135-710