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

Not Applicable

• Conditions: Stomach Cancer; Liver Cancer; Bile Duct Cancer; Pancreas Cancer
• Interventions: Device: Endovascular Denervation

• Registration Number: NCT04014478
• Lead Sponsor: Shanghai Golden Leaf MedTec Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Study First Posted: 2019-07-10
• Last Update Posted: 2019-07-10
• Study Start: 2019-07-15
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular Denervation	Endovascular Denervation	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.