Clinical Trial: ComVi and D-type Stent in Malignant GOO

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Mult

Brief Summary: Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.

Detailed Summary:
Sponsor: Ajou University School of Medicine

Current Primary Outcome: the stent patency time from stent insertion to restenosis due to stent malfunction or death [ Time Frame: Up to 1 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate [ Time Frame: up to 1 years ]

Original Secondary Outcome: Same as current

Information By: Ajou University School of Medicine

Dates:
Date Received: April 18, 2013
Date Started: April 2010
Date Completion:
Last Updated: April 22, 2013
Last Verified: April 2013