Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Palliation assessment based on Dysphagia Scores
Study Overview
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:
- 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
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;
Secondary Outcomes
- Assessment of Complications and MD Anderson Dysphagia Score(2-4 years)
Investigators
Michel Kahaleh
Chief, Advanced Endoscopy
Weill Medical College of Cornell University