A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent
NCT ID: NCT05220475
Last Updated: 2022-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2021-10-25
2024-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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fc-SEMS with anchoring plastic stent
fully covered self-expanable metal stent with an external anchoring plastic stent
fully covered self-expandable metal stent with an anchoring external plastic stent
Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
uc-SEMS
uncovered self-expandable metal stent
uncovered self-expandable metal stent
Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent
Interventions
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fully covered self-expandable metal stent with an anchoring external plastic stent
Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
uncovered self-expandable metal stent
Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent
Eligibility Criteria
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Inclusion Criteria
* Those who voluntarily consented to the trial and signed a written consent
* Inoperable malignant biliary obstruction
Exclusion Criteria
* Patients continuosly requiring percutaneous transhepatic biliary drainage
* History of biliary drainage with metal stent
* Biliary obstruction located in hilum or intrahepatic duct
* Patients with life expectancy of 3 months or less
* On pregnancy
* Unable to underwent endoscopic procedures
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Sang Hyub Lee
Professor
Principal Investigators
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Sang Hyub Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sang Hyub Lee, MD, PhD
Role: primary
Other Identifiers
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H-2012-043-1179
Identifier Type: -
Identifier Source: org_study_id
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