A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain

Conditions
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Liver Cancer, Pancreas Cancer, Stomach Cancer, Bile Duct Cancer

Intervention / Treatment
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* Device: Endovascular Denervation


Participation Criteria
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Eligibility Criteria
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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.

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> | Device: Endovascular Denervation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Changes over the time | 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. | Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Equivalent Changes over the time | All analgesics used will be calculated to Morphine Equivalent using published conversion factors. | Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. | 
| Quality of Life Score Changes over the time | 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. | Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer； Pain