The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Asan Medical Center
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Complication rate(stent migration and tumor ingrowth) of new designed winged stent
Study Overview
Brief Summary
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
winged stent group
participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
Intervention: Winged stent (partially covered) (Device)
winged stent group
participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
Intervention: Winged stent (uncovered) (Device)
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)
Investigators
Ji Yong Ahn
Assistant Professor
Asan Medical Center