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

Phase 2

Withdrawn

• Conditions: Esophageal Cancer
• Interventions: Device: HANAROSTENT TM covered Esophageal Stent

• Registration Number: NCT01301495
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-20
• Study First Posted: 2011-02-23
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HANAROSTENT covered Esophageal Stent	HANAROSTENT TM covered Esophageal Stent	-

Primary Outcome Measures

Name	Time	Method
Palliation assessment based on Dysphagia Scores	2 years	To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;

Secondary Outcome Measures

Name	Time	Method
Assessment of Complications and MD Anderson Dysphagia Score	2-4 years	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

Trial Locations

Locations (1)

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States