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

Shanghai Golden Leaf MedTec

Status

Unknown

Conditions

Bile Duct Cancer

Pancreas Cancer

Stomach Cancer

Liver Cancer

Treatments

Device: Endovascular Denervation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04014478

GL-CT-20161201

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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.