Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Palliation assessment based on Dysphagia Scores
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inoperable malignant obstruction of the esophageal or gastric cardia
- •Malignant fistula between the esophagus ans respiratory tree
- •Recurrent cancer after prior radiation
排除标准
- •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)
结局指标
主要结局
Palliation assessment based on Dysphagia Scores
时间窗: 2 years
To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
次要结局
- Assessment of Complications and MD Anderson Dysphagia Score(2-4 years)
研究者
Michel Kahaleh
Chief, Advanced Endoscopy
Weill Medical College of Cornell University