The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents

Study Overview
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Brief Summary
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The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).

Official Title
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The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents

Conditions
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Malignant Gastric Outlet Obstruction

Intervention / Treatment
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* Device: Winged stent (partially covered)
* Device: Winged stent (uncovered)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric outlet obstruction symptom Diagnosis of gastric outlet obstruction by radiologist or endoscopist Gastric outlet obstruction by malignant disease Aged over 19 Informed consent Exclusion Criteria: Gastric outlet obstruction by benign disease or infectious disease Could not endoscopic intervention by poor general condition Refusal of patient

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: winged stent group<br>participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS). | Device: Winged stent (partially covered)<br>* A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.<br>Device: Winged stent (uncovered)<br>* A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate(stent migration and tumor ingrowth) of new designed winged stent | It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging. | up to 16 weeks from stent insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the technical success rate of SEMS insertion | It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging. | up to 16 weeks from stent insertion | 
| Evaluate the clinical success rate of SEMS insertion | It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging. | up to 16 weeks from stent insertion | 
| Difference of insertion time between previous stent insertion and new designed stent |  | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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winged stents, Self-expandable Metal Stents(SEMS), partial covered, uncovered, endoscopic insertion