Clinical trial NCT04014478: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Pancreas Cancer
Stomach Cancer
Bile Duct Cancer
Keywords: Cancer； Pain
Lead sponsor: Shanghai Golden Leaf MedTec Co. Ltd
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 110
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Visual Analog Scale Changes over the time
timeFrame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Secondary outcomes:
measure: Morphine Equivalent Changes over the time
timeFrame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
measure: Quality of Life Score Changes over the time
timeFrame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, MD
role: STUDY_CHAIR
affiliation: Shanghai JiaoTong University Affiliated RuiJin Hospital
name: zhong-Min Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing University Affiliated the First Hospital
name: Jian Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University Affiliated Cancer Hospital
name: Wen-Tao Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HuaZhong University of Science and Technology Affiliated Union Hospital
name: Chuan-Sheng Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: China University of Science and Technology Affiliated the First Hospital
name: Wei-Fu Lv, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University Affiliated the First Hospital
name: Jun-Hui Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: XuZhou Medical College Affiliated Hospital
name: Hao Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yunnan Cancer Hospital
name: Ming Huang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The People's Hospital of Zhuhai City
name: Li-Gong Lu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Lishui City
name: Jian-Song Ji, MD
role: PRINCIPAL_INVESTIGATOR
References: