- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01301495
Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
Study Overview
Status
Conditions
Intervention / Treatment
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:
- To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
- 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 Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Medical College of Cornell University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HANAROSTENT 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Palliation assessment based on Dysphagia Scores
Time Frame: 2 years
|
To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Complications and MD Anderson Dysphagia Score
Time Frame: 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
|
2-4 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michel Kahaleh, M.D., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14989
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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