A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
Primary Purpose
Liver Cancer, Pancreas Cancer, Stomach Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovascular Denervation
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Cancer; Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endovascular Denervation
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Morphine Equivalent Changes over the time
All analgesics used will be calculated to Morphine Equivalent using published conversion factors.
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.
Full Information
NCT ID
NCT04014478
First Posted
July 1, 2019
Last Updated
July 8, 2019
Sponsor
Shanghai Golden Leaf MedTec Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04014478
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Anticipated)
Primary Completion Date
July 15, 2021 (Anticipated)
Study Completion Date
July 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Golden Leaf MedTec Co. Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Pancreas Cancer, Stomach Cancer, Bile Duct Cancer
Keywords
Cancer; Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endovascular Denervation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endovascular Denervation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale Changes over the time
Description
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.
Time Frame
Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Secondary Outcome Measure Information:
Title
Morphine Equivalent Changes over the time
Description
All analgesics used will be calculated to Morphine Equivalent using published conversion factors.
Time Frame
Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
Title
Quality of Life Score Changes over the time
Description
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.
Time Frame
Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Qing Yin, PhD
Phone
86-21-5486-8731
Email
huaqing.yin@goldenleafmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, MD
Organizational Affiliation
Zhongda Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
zhong-Min Wang, MD
Organizational Affiliation
Shanghai JiaoTong University Affiliated RuiJin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian Wang, MD
Organizational Affiliation
Beijing University Affiliated the First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wen-Tao Li, MD
Organizational Affiliation
Fudan University Affiliated Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chuan-Sheng Zheng, MD
Organizational Affiliation
HuaZhong University of Science and Technology Affiliated Union Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei-Fu Lv, MD
Organizational Affiliation
China University of Science and Technology Affiliated the First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun-Hui Sun, MD
Organizational Affiliation
Zhejiang University Affiliated the First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hao Xu, MD
Organizational Affiliation
XuZhou Medical College Affiliated Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming Huang, MD
Organizational Affiliation
Yunnan Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li-Gong Lu, MD
Organizational Affiliation
The People's Hospital of Zhuhai City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian-Song Ji, MD
Organizational Affiliation
The Central Hospital of Lishui City
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
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