Brief Title
A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
Official Title
A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain
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.
Study Type
Interventional
Primary Outcome
Visual Analog Scale Changes over the time
Secondary Outcome
Morphine Equivalent Changes over the time
Condition
Liver Cancer
Intervention
Endovascular Denervation
Study Arms / Comparison Groups
Endovascular Denervation
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
110
Start Date
July 15, 2019
Completion Date
July 15, 2021
Primary Completion Date
July 15, 2021
Eligibility Criteria
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.
Gender
All
Ages
25 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Gao-Jun Teng, MD, 86-21-5486-8731, [email protected]
Administrative Informations
NCT ID
NCT04014478
Organization ID
GL-CT-20161201
Responsible Party
Sponsor
Study Sponsor
Shanghai Golden Leaf MedTec Co. Ltd
Study Sponsor
Gao-Jun Teng, MD, Study Chair, Zhongda Hospital
Verification Date
June 2019