Clinical Trial: Outcome Study of Double Bare Stent for Malignant Gastric Outlet Obstruction
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
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 Summary:
Sponsor: National Cancer Center, Korea
Current Primary Outcome: The patency rate at 8 weeks after placement. [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Technical and clinical success rates [ Time Frame: up to 8 weeks ]
- re-stenosis rate [ Time Frame: 8 weeks ]
- migration rate [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: National Cancer Center, Korea
Dates:
Date Received: June 2, 2014
Date Started: January 2013
Date Completion: July 2015
Last Updated: June 4, 2014
Last Verified: June 2014
