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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COMPLETED
NA
89 participants
INTERVENTIONAL
2010-04-30
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
SUPPORTIVE_CARE
NONE
Study Groups
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uncovered D-type stent
uncovered D-type stent, which effectively reduces stent migration, especially in malignant colorectal obstruction
uncovered D-type stent insertion
double-layered ComVi stent
double-layered ComVi stent, which is a modified covered stent with an additional outer bare wire mesh to overcome both tumor ingrowth and stent migration
double-layered ComVi stent insertion
Interventions
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uncovered D-type stent insertion
double-layered ComVi stent insertion
Eligibility Criteria
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Inclusion Criteria
* obstructive symptoms due to unresectable malignant GOO
* a Karnofsky performance score of more than 30 (13)
Exclusion Criteria
* the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
* severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
* a life expectancy of less than 1 month after SEMS insertion
* history of gastric surgery
18 Years
ALL
No
Sponsors
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National Cancer Center, Korea
OTHER_GOV
Kyungpook National University Hospital
OTHER
Hallym University
OTHER
The Catholic University of Korea
OTHER
Seoul National University
OTHER
DongGuk University
OTHER
Ajou University School of Medicine
OTHER
Responsible Party
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Sun Gyo Lim
Assistant professor
Principal Investigators
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Jin Hong Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Locations
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Ajou University Hospital
Suwon, , South Korea
Countries
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Other Identifiers
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AJIRB-DEV-DE4-10-009
Identifier Type: -
Identifier Source: org_study_id
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