Clinical Trial: Fully Covered or Partially Covered Stents in Malignant Esophageal Strictures

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Comparison of a Fully Covered Self Expandable Metal Stent Versus a Partially Covered Self Expandable Metal Stent in Malignant Esophageal Strictures

Brief Summary: The purpose of this study is to determine whether fully covered or partially covered metal stents are more favorable in incurable malignant stenosis of the esophagus or cardia. Primary outcome will be the occurence of recurrent dysphagia which is defined as dysphagia due to a stent or tumour related cause in a 6-month follow-up

Detailed Summary:
Sponsor: Foundation for Liver Research

Current Primary Outcome: Recurrent dysphagia. [ Time Frame: From stent placement (t=0) until death or placement of second stent, assessed up to 6 months. ]

This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical success of SEMS placement [ Time Frame: At stent placement (t=0) ]
  • Clinical success defined as improvement of dysphagia score [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ]
    dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months
  • Major and minor complication rate [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months ]
  • Quality of Life [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ]
    This will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 and the EOS18, at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months.
  • Survival [ Time Frame: From stent placement until death or placement of second stent, assessed up to 6 months. ]


Original Secondary Outcome: Same as current

Information By: Foundation for Liver Research

Dates:
Date Received: August 1, 2012
Date Started: July 2012
Date Completion: October 2016
Last Updated: August 16, 2016
Last Verified: August 2016