Endovascular Denervation in Patients With Cancer Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
Endovascular arterial denervation (ED) is a minimally invasive technique which could reduce the occurrence of injury of visceral tissue or organs. As the principle of renal denervation (RDN), Radiofrequency energy delivered by a multi-electrode catheter to the celiac plexus over the anterolateral surface of the superior mesenteric artery (SMA) and the celiac axis. Damaged or partially damaged celiac plexus can achieve the effect of pain relief.
详细描述
The multi-electrode catheter was consisted of six independent electrodes helically on a net structure, which could be set as the same energy and temperature for simultaneous multi-point ablation. A real-time monitoring capability also provided by the display.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 to 75 years
- •severe cancer pain with the visual analogue scores of no less than 7
排除标准
- •pregnant or intent to become pregnant within 1 year
- •postural hypotension
- •uncorrected coagulation dysfunction
- •aortic aneurysm or dissection
- •type 1 diabetes mellitus (T1DM)
- •acute or severe systemic infection
- •history of cerebral apoplexy or transient ischemic attack (TIA) in the past two weeks
- •history of acute coronary syndrome in the past two weeks
- •participants who are not suitable to be enrolled into the study assessed by the researchers
研究组 & 干预措施
endovascular denervation
endovascular denervation
干预措施: endovascular denervation (Device)
结局指标
主要结局
Pain relief
时间窗: from baseline to 1 months after procedure
Changes of the visual analogue scores (VAS) scores
次要结局
- Pain relief(from baseline to 3 months after procedure)
- Improvement of Quality of Life(from baseline to 3 months after procedure)
- Incidence of Treatment Adverse Events(from baseline to 1 months after procedure)
研究者
Gao-jun Teng
Dean
Zhongda Hospital