Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction
Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
1 other identifier
interventional
106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 12, 2015
September 1, 2014
2 years
September 30, 2014
February 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
duration of stent patency
From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
Secondary Outcomes (3)
overall survival
From the date of randomization until the date of death from any cause, assessed upto 12 months
stent occlusion rate
From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months
stent related complication
From the date of randomization until the date of first documented stent related complication, assessed up to 12 months
Study Arms (2)
partially covered SEMS
ACTIVE COMPARATORDeployment of Partially covered biliary self expandable metal stent
fully covered SEMS
ACTIVE COMPARATORDeployment of Fully covered biliary self expandable metal stent
Interventions
Used for palliation of inoperable malignant distal bile duct obstruction.
Used for palliation of inoperable malignant distal bile duct obstruction.
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Cencer
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Kyun Lee, M.D., Ph.D.
Samsung Medical Cencer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 2, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
February 12, 2015
Record last verified: 2014-09