Gastric Outlet Obstruction Due to Malignancy Clinical Trial
Official title:
Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
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.
| Status | Recruiting |
| Enrollment | 49 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | National Cancer Center | Goyang | Gyeonggi |
| Lead Sponsor | Collaborator |
|---|---|
| National Cancer Center, Korea | Stent research group, Korean Society of Gastrointestinal Endoscopy, Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The patency rate at 8 weeks after placement. | 8 weeks | No | |
| Secondary | Technical and clinical success rates | up to 8 weeks | No | |
| Secondary | re-stenosis rate | 8 weeks | No | |
| Secondary | migration rate | 8 weeks | No |