跳至主要内容
临床试验/NCT01366833
NCT01366833终止不适用

Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
2
主要终点
To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks

研究概览

简要总结

According to the Canadian Cancer Society there are approximately 1700 new cases of esophageal cancer per year in Canada. As most of these patients are diagnosed in advanced stages of the disease, 1800 deaths are estimated from this cancer annually . Progressive dysphagia is the most common presenting symptom and impacts not only the patient's quality of life but the ability to tolerate life prolonging treatments such as systemic chemotherapy.

Although there are several therapeutic modalities to alleviate malignant dysphagia including laser, photodynamic therapy and cryotherapy , the use of stents and radiotherapy are the most commonly employed. However, the optimal approach to effective, timely treatment of malignant dysphagia remains a challenge. The investigators conducted a preliminary retrospective review to investigate such palliation procedures and found that a multi-modality approach may yield the most favourable results .

Therefore, our clinical trial will examine the effectiveness of adding a single dose of brachytherapy to patients with severe dysphagia who have already been treated with a endoscopically placed self-expanding metallic stent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Age ≥18 years
  • Confirmed esophageal/gastroesophageal (GEJ) cancer (Siewert Type I and Type II only) of any histology on biopsy
  • Dysphagia score ≥2
  • Stage IV cancer/Metastatic disease

排除标准

  • Expected life expectancy < 3 months
  • Inability to undergo stent insertion
  • Siewert Type III gastroesophageal cancer
  • Esophageal-Airway fistula

结局指标

主要结局

To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorenzo Ferri

Dr.

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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