Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees.
研究概览
简要总结
The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.
详细描述
The centering of radiotherapy is done with the pre-radiation scanner for tracking the implementation of target skin markers. On this scanner, it is often difficult for the radiation therapist to pinpoint the target volume. To improve the definition of the target volume, image fusion techniques with other imaging tests were developed.
To improve the pre-radiotherapy identification, setting up markers echo-endoscopy has been described without major complications. The impact on targeting radiotherapy was mainly described for the prostate.
The marking of digestive tumors was described by the establishment of Trustees, radiopaque markers in the lymph nodes, esophagus, stomach, pancreas, and bile ducts.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Male or female over the age of 18
- •Rectal cancer diagnosis or esophagus
- •Radiotherapy indication
- •Signed consent to participate
- •Patient affiliated to a social security system or benefiting from such a system
排除标准
- •Pregnant women, of child-bearing potential, or lactating women
- •Patient deprived of liberty or under supervision of a guardian
- •Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
- •Contra-indication for procedure study (infeasible EUS)
- •Contra-indication for general anesthesia
- •Patient (e) with disorders of hemostasis
- •Patient (e) with portal hypertension
结局指标
主要结局
Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees.
时间窗: From inclusion to 12 months follow up
Observing whether there is a significant variation of the area to be irradiated
次要结局
- Number of trustees (2 up 6 maximum) and set up their positions estimated success rate of implementation and the evaluation of the safety and toxicity (complications) associated with the establishment trustees (composite measure)(From inclusion to 12 months follow up)