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

Study Overview
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Brief Summary
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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

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

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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Device: HANAROSTENT TM covered Esophageal Stent


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HANAROSTENT covered Esophageal Stent<br> | Device: HANAROSTENT TM covered Esophageal Stent<br>* HANAROSTENT covered Esophageal Stent for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula<br>* Other names: HANAROSTENT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Complications and MD Anderson Dysphagia Score | 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 | 2-4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer