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

This study is currently recruiting participants.
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Collaborator:
M.I.Tech Co., Ltd.
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01301495
First received: February 17, 2011
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Esophageal Cancer
 Device: HANAROSTENT TM covered Esophageal Stent
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Palliation assessment based on Dysphagia Scores [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;


Secondary Outcome Measures:
  • Assessment of Complications and MD Anderson Dysphagia Score [ Time Frame: 2-4 years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: HANAROSTENT

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301495

Contacts
Contact: Michel Kahale, MD 646-962-4797 mkahaleh@gmail.com
Contact: Monica R Gaidhane, MPH 646-962-4796 mog2012@med.cornell.edu

Locations
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Contact: Michel Kahaleh, M.D.     646-962-4797     mkahaleh@gmail.com    
Contact: Monica Gaidhane, M.P.H     646-962-4796     mog2012@med.cornell.edu    
Principal Investigator: Michel Kahaleh, M.D.            
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
  More Information

No publications provided

Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01301495     History of Changes
Other Study ID Numbers: 14989
Study First Received: February 17, 2011
Last Updated: December 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013