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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04014478
• Other study ID #: GL-CT-20161201
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: June 2019
• Source: Shanghai Golden Leaf MedTec Co. Ltd
• Contact: Hua Qing Yin, PhD
• Phone: 86-21-5486-8731
• Email: huaqing.yin[@]goldenleafmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cancer Pain
• Cholangiocarcinoma
• Liver Cancer
• Liver Neoplasms
• Pancreas Cancer
• Pancreatic Neoplasms
• Stomach Cancer
• Stomach Neoplasms

Intervention

Device:
• Endovascular 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Golden Leaf MedTec Co. Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.