Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- The patency rate at 8 weeks after placement.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
DoubleBare stent
Placement of double bare stent
Intervention: placement of double bare stent (Procedure)
DoubleBare stent
Placement of double bare stent
Intervention: DoubleBare stent (Device)
Outcomes
Primary Outcomes
The patency rate at 8 weeks after placement.
Time Frame: 8 weeks
Secondary Outcomes
- Technical and clinical success rates(up to 8 weeks)
- re-stenosis rate(8 weeks)
- migration rate(8 weeks)
Investigators
Chan Gyoo Kim
Senior scientist
National Cancer Center, Korea