Cancer Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEendovascular denervation
multi-electrode catheter-based endovascular denervation
Sponsors
Zhongda Hospital
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
* 25 to 75 years * severe cancer pain with the visual analogue scores of no less than 7
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | from baseline to 1 months after procedure | Changes of the visual analogue scores (VAS) scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain relief | from baseline to 3 months after procedure | Changes of the visual analogue scores (VAS) scores |
| Improvement of Quality of Life | from baseline to 3 months after procedure | Changes of the 100-item World Health Organization Quality of Life (QOL) |
| Incidence of Treatment Adverse Events | from baseline to 1 months after procedure | Assess artery damage, such as abdominal aortic dissection and abdominal aneurysm, by digital subtraction angiography or computed tomography |
Countries
China
Contacts
Primary ContactGao-Jun Teng, MD
Backup ContactQi Zhang, PhD
Outcome results
None listed