Gastric Outlet Obstruction Due to Malignancy
Conditions
Keywords
stent, gastric outlet obstruction, restenosis
Brief summary
Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.
Interventions
PROCEDUREplacement of double bare stent
DEVICEDoubleBare stent
Sponsors
Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Malignant gastric outlet obstruction * Symptoms compatible with gastric outlet obstruction * An inoperable condition because of extent of disease or patient's conditions
Exclusion criteria
* History of enteral stent placement, undergone gastric surgery. * Additional small bowel stenosis distal to gastric outlet obstruction. * Refuse to be enrolled to study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patency rate at 8 weeks after placement. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Technical and clinical success rates | up to 8 weeks |
| re-stenosis rate | 8 weeks |
| migration rate | 8 weeks |
Countries
South Korea
Contacts
Primary ContactChan G Kim, M.D.
Outcome results
None listed