Quality of Life and Dysphagia Following Palliative Stenting in Esophageal Cancer (CT0023)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- improvement of dysphagia post stenting
研究概览
简要总结
This study consists of a prospective clinical trial which aims to evaluate the impact of stent insertion for palliation of malignant dysphagia. The main goal being to examine the number of days required following stenting in order to have significant improvement in dysphagia and the length of time that this baseline is maintained. Approximately 100 patients will be prospectively enrolled in this study.
Patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertion will be prospectively enrolled into the study. Patients with esophageal obstruction or stricture due to other benign causes, tumors obstructing the cervical esophagus, as well as patients with airway-esophageal fistulas will be excluded from the study.
The investigators plan to evaluate the efficacy of intra-esophageal stent insertion to improve malignant dysphagia as a main factor affecting the quality of life in these patients.
详细描述
Esophageal cancer is one of the 10 most frequent cancers in the world. The incidence of esophageal cancer is rapidly increasing and is doing so at a more rapid rate than any other cancer in the western world. The annual incidence reported in western countries is 3 per 100,000. In central China it has been reported to be as high as 140 per 100,000 in Linxian Province in central China.
Esophageal cancer remains one of the most lethal of all malignancies. Once a diagnosis is established, the prognosis is poor, with a 5-year survival rate of less than 10%. Despite advances in therapy, more than 50% of patients have incurable disease at the time of presentation and only one third of patients with localized disease experience long term survival.
By the appearance of dysphagia and by the time of diagnosis, most patients are not candidates for esophagectomy because symptoms are not present until at least 50% of the circumference of the oesophagus is involved. Distant metastasis will usually be established by this time.
The symptoms of dysphagia and weight loss that are commonly experienced have a significant impact on quality of life for these patients. This makes palliative endoluminal stenting an attractive option. The mainstay of treatment is the palliation of dysphagia resulting from malignant stenosis and intraluminal tumor growth.
A number of palliative therapies are available to the treating physician. The options for treating dysphagia that is caused by advanced, unresectable esophageal cancer include: stenting, photodynamic therapy (PDT), thermal laser ablation, external beam radiation and brachytherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •All patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertions.
排除标准
- •Inability to consent for the study.
- •Patients less than 18 years old.
- •Patients with other benign causes of dysphagia and esophageal obstruction or stenosis.
- •Patients with malignant or benign airway - esophageal fistulas.
- •Patients with cervical esophageal cancer
结局指标
主要结局
improvement of dysphagia post stenting
时间窗: 3 months
To assess the effectiveness of esophageal stenting in improving malignant dysphagia and assess the time period relating to this improvement
次要结局
- Quality of life post stenting(3 months)