Liver Cancer, Pancreas Cancer, Stomach Cancer, Bile Duct Cancer
Conditions
Keywords
Cancer； Pain
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.
Interventions
DEVICEEndovascular Denervation
A radiofrequency ablation catheter will be placed in abdominal aorta. At least 6 sites will be ablated with settings of temerature at 60 degree centigrade and time at 120 seconds.
Sponsors
Shanghai Golden Leaf MedTec Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Changes over the time | 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
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalent Changes over the time | Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. | All analgesics used will be calculated to Morphine Equivalent using published conversion factors. |
| Quality of Life Score Changes over the time | Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. | Qulaity of Life Scores are obtained using Functional Assessment of Cancer Theray-Generic Scale (FACT-G) (v 4.0) sale. The score is from 0 to 108, with 0 being no quality of life, and 108 being highest quality of life. |
Contacts
Primary ContactHua Qing Yin, PhD
Outcome results
None listed