Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
The incidence of esophageal cancer is increasing, and despite advances in treatment, the
prognosis is still very poor [1-4]. At presentation, between 50-60 % of patients have
unresectable disease [5,6]. For these patients, palliation is the goal with a particular
focus on the relief of dysphagia, which is the major etiology of morbidity [5,6]. Presently,
Self expanding metal stent (SEMS) have become the treatment of choice for dysphagia
associated with unresectable esophageal and GE junction malignancies.
In this study, a newly designed and FDA approved fully covered metal stents will be used to
palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be
assessed before and after treatment to confirm efficacy
The objectives are:
1. To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate
palliation of cancerous lesions of the esophagus;
2. To determine whether it is non-inferior in efficacy and safety to the esophageal stents
currently available at UVa with minimal complications and improvement of symptoms
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Palliation assessment based on Dysphagia Scores
To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
2 years
Yes
Michel Kahaleh, M.D.
Principal Investigator
Weill Medical College of Cornell University
United States: Institutional Review Board
14989
NCT01301495
November 2010
December 2013
Name | Location |
---|---|
Weill Medical College of Cornell University | New York, New York 10021 |