Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction
Phase 4
- Conditions
- Gastric Outlet Obstruction Due to Malignancy
- Interventions
- Procedure: placement of double bare stentDevice: DoubleBare stent
- Registration Number
- NCT02156505
- Lead Sponsor
- National Cancer Center, Korea
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 49
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DoubleBare stent placement of double bare stent Placement of double bare stent DoubleBare stent DoubleBare stent Placement of double bare stent
- Primary Outcome Measures
Name Time Method The patency rate at 8 weeks after placement. 8 weeks
- Secondary Outcome Measures
Name Time Method Technical and clinical success rates up to 8 weeks re-stenosis rate 8 weeks migration rate 8 weeks
Trial Locations
- Locations (1)
National Cancer Center
🇰🇷Goyang, Gyeonggi, Korea, Republic of