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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01301495
Collaborator
M.I.Tech Co., Ltd. (Other)
0
Enrollment
1
Location
1
Arm
36
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: HANAROSTENT TM covered Esophageal Stent
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: HANAROSTENT covered Esophageal Stent

Device: 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
Other Names:
  • HANAROSTENT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Medical College of Cornell University New York New York United States 10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • M.I.Tech Co., Ltd.

    Investigators

    • Principal Investigator: Michel Kahaleh, M.D., Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT01301495
    Other Study ID Numbers:
    • 14989
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Jun 3, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
    Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Jun 3, 2015