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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01301495

Enrollment

Registered

2011-02-23

Start date

2010-11-30

Completion date

2013-11-30

Last updated

2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer

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

Interventions

DEVICEHANAROSTENT TM covered Esophageal Stent

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026