NCT02440724
Unknown
Not Applicable
The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
ConditionsMalignant Gastric Outlet Obstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Gastric Outlet Obstruction
- Sponsor
- Asan Medical Center
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Complication rate(stent migration and tumor ingrowth) of new designed winged stent
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
Investigators
Ji Yong Ahn
Assistant Professor
Asan Medical Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Complication rate(stent migration and tumor ingrowth) of new designed winged stent
Time Frame: up to 16 weeks from stent insertion
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
Secondary Outcomes
- Evaluate the clinical success rate of SEMS insertion(up to 16 weeks from stent insertion)
- Evaluate the technical success rate of SEMS insertion(up to 16 weeks from stent insertion)
- Difference of insertion time between previous stent insertion and new designed stent(1 years)
Study Sites (1)
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