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

NCT ID: NCT01301495

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-11-30

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

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HANAROSTENT covered Esophageal Stent

Group Type: EXPERIMENTAL

HANAROSTENT TM covered Esophageal Stent

Intervention Type: DEVICE

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

Interventions

HANAROSTENT 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

Intervention Type: DEVICE

Other Intervention Names

HANAROSTENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.I.Tech Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Michel Kahaleh

Chief, Advanced Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Kahaleh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

Other Identifiers

14989

Identifier Type: -

Identifier Source: org_study_id