Clinical Trial: The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents

Brief Summary: The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).

Detailed Summary:
Sponsor: Asan Medical Center

Current Primary Outcome: Complication rate(stent migration and tumor ingrowth) of new designed winged stent [ Time Frame: up to 16 weeks from stent insertion ]

It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate the technical success rate of SEMS insertion [ Time Frame: up to 16 weeks from stent insertion ]
    It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
  • Evaluate the clinical success rate of SEMS insertion [ Time Frame: up to 16 weeks from stent insertion ]
    It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
  • Difference of insertion time between previous stent insertion and new designed stent [ Time Frame: 1 years ]


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: May 4, 2015
Date Started: August 2014
Date Completion: December 2015
Last Updated: May 7, 2015
Last Verified: May 2015