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

This study has been withdrawn prior to enrollment.
(No participants enrolled for more than 1 year.)
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: June 10, 2014
Last verified: June 2014
  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:


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


Enrollment: 0
Study Start Date: November 2010
Study Completion Date: November 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301495

Locations
United States, New York
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
  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: June 10, 2014
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 Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014