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

Weill Cornell Medicine (WCM)

Status and phase: Withdrawn; Phase 2

Conditions: Esophageal Cancer

Treatments: Device: HANAROSTENT TM covered Esophageal Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01301495

14989

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

HANAROSTENT covered Esophageal Stent

Experimental group

Treatment:

Device: HANAROSTENT TM covered Esophageal Stent