Malignant Gastric Outlet Obstruction
Conditions
Keywords
winged stents, Self-expandable Metal Stents(SEMS), partial covered, uncovered, endoscopic insertion
Brief summary
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
Interventions
DEVICEWinged stent (partially covered)
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.
DEVICEWinged stent (uncovered)
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.
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Gastric outlet obstruction symptom 2. Diagnosis of gastric outlet obstruction by radiologist or endoscopist 3. Gastric outlet obstruction by malignant disease 4. Aged over 19 5. Informed consent
Exclusion criteria
1. Gastric outlet obstruction by benign disease or infectious disease 2. Could not endoscopic intervention by poor general condition 3. Refusal of patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate(stent migration and tumor ingrowth) of new designed winged stent | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the technical success rate of SEMS insertion | 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. |
| Evaluate the clinical success rate of SEMS insertion | 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. |
| Difference of insertion time between previous stent insertion and new designed stent | 1 years | — |
Countries
South Korea
Contacts
Primary Contactmyungeun lee, BA
Backup ContactSojung Park, BA
Outcome results
None listed