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Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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


Inclusion Criteria:



- Inoperable malignant obstruction of the esophageal or gastric cardia

- Malignant fistula between the esophagus ans respiratory tree

- Recurrent cancer after prior radiation

Exclusion Criteria:

- Patient unstable for endoscopic procedure

- Previous esophageal stenting

- Tumor growth within 2 cm of the upper esophageal sphincter

- Pregnant women (self reported, no pregnancy test will be done per protocol)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Palliation assessment based on Dysphagia Scores

Outcome Description:

To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Michel Kahaleh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

14989

NCT ID:

NCT01301495

Start Date:

November 2010

Completion Date:

December 2013

Related Keywords:

  • Esophageal Cancer
  • Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021