A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 主要终点
- Visual Analog Scale Changes over the time
研究概览
简要总结
A prospective, multicenter, self-control clinical trial aim to enroll 110 patients suffered from upper abdominal (liver, pancreas, stomach, etc.) cancers . Patients who have taken at least one opioid drug for pain for two weeks and still have a VAS pain scale greater than 6 will receive endovascular denervation (EDN). They will be followed up for 3 months. The VAS scales, quantity of analgesics as represented by morphine equivalent and quality of life scores will be compared before and after EDN. Safety parameters such as arterial deformation, embolism, infection, liver and kidney functions will also be monitored.
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
- •Males or females with ages of 25 to 75;
- •Clinically diagnosed as primary or secondary upper abdominal cancers (liver, pancreas, stomach, etc);
- •Patients who have taken at least one opioid drug for pain for two weeks and still have VAS pain scale 》6;
- •Expected lifetime 》4 months;
- •Agrees to take part in the trial and signs the written, informed consent.
排除标准
- •Women who are pregnant, or breast feeding, or having pregancy plan;
- •Bleeding tendency or other coagulation related diseases;
- •Acute or severe systemic infection;
- •Past history of receving denervation procedure in aorta;
- •No plans for surgical or interventional procedures in 3 months;
- •History of stroke or TIA within 2 weeks;
- •Acute coronary events within 2 weeks;
- •Other conditions that deem unsuitable for the procedure, in the opinions of investigators.
研究组 & 干预措施
Endovascular Denervation
干预措施: Endovascular Denervation (Device)
结局指标
主要结局
Visual Analog Scale Changes over the time
时间窗: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Pain scale is evaluated as Woodforde Visual Analig Scale (VAS) method. The scale is from 0 to 10, with 0 being no pain, and 10 being unbearable pain.
次要结局
- Quality of Life Score Changes over the time(Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.)
- Morphine Equivalent Changes over the time(Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.)