Endovascular Denervation in Patients With Cancer Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endovascular Denervation in Patients With Cancer Pain

Conditions
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Cancer Pain

Intervention / Treatment
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* Device: endovascular denervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endovascular denervation<br>endovascular denervation | Device: endovascular denervation<br>* multi-electrode catheter-based endovascular denervation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Changes of the visual analogue scores (VAS) scores | from baseline to 1 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Changes of the visual analogue scores (VAS) scores | from baseline to 3 months after procedure | 
| Improvement of Quality of Life | Changes of the 100-item World Health Organization Quality of Life (QOL) | from baseline to 3 months after procedure | 
| Incidence of Treatment Adverse Events | Assess artery damage, such as abdominal aortic dissection and abdominal aneurysm, by digital subtraction angiography or computed tomography | from baseline to 1 months after procedure |