NCT00727376已完成不适用
Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation
研究概览
简要总结
To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age and older
- •Willing and able to provide informed consent
- •Willing to comply with follow-up requirements
- •Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less)
- •Indicated for chemotherapy and/or radiation therapy
- •Ability to dilate stricture to 15mm diameter at extent of disease evaluation
- •Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent
排除标准
- •Patients contraindicated for endoscopy
- •Patients with prior esophageal stent placements
- •Advance stage of disease, greater than T3 tumor or M1 disease
结局指标
主要结局
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation
时间窗: 8 - 10 weeks
次要结局
未报告次要终点
研究者
Robert C. Martin
Professor
University of Louisville
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal CancerEsophageal CancerNCT00477841Southeast University, China60
撤回
不适用
Use of Metal Stents on Benign Esophageal LesionsBenign Esophageal LesionsNCT01238913University of Florida
已完成
不适用
Role of Radiotherapy Following Oesophageal Stenting in CancerOesophageal CancerNCT01179074All India Institute of Medical Sciences, New Delhi84
已完成
不适用
An Observational Clinical Feasibility Study of the Magnetic Esophageal SphincterGastroesophageal Reflux DiseaseNCT01058070Torax Medical Incorporated44
终止
不适用
Intermittent Oral-esophageal Tube in Delayed Dysphagia After Radiotherapy for Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT06248840Zeng Changhao56