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

Weill Medical College of Cornell University

Overview

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 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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Esophageal Cancer

Interventions

HANAROSTENT TM covered Esophageal StentDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Weill Medical College of Cornell University

New York, New York, United States

Outcomes

Primary Outcomes

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;

Time frame: 2 years

Secondary Outcomes

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

Time frame: 2-4 years

Data from ClinicalTrials.gov

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