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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
Shanghai Golden Leaf MedTec Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Cancer； Pain

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    July 1, 2019
    Last Updated
    July 8, 2019
    Sponsor
    Shanghai Golden Leaf MedTec Co. Ltd
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    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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