A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Cancer
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
- Enrollment
- 110
- Primary Endpoint
- Visual Analog Scale Changes over the time
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Visual Analog Scale Changes over the time
Time Frame: 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.
Secondary Outcomes
- 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.)