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出境医 / 临床实验 / A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain

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

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Pancreas Cancer Stomach Cancer Bile Duct Cancer Device: Endovascular Denervation Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : July 15, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Endovascular Denervation Device: Endovascular Denervation
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.
Outcome Measures
Primary Outcome Measures :
  1. Visual Analog Scale Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]
    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 :
  1. Morphine Equivalent Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]
    All analgesics used will be calculated to Morphine Equivalent using published conversion factors.

  2. Quality of Life Score Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hua Qing Yin, PhD 86-21-5486-8731 huaqing.yin@goldenleafmed.com

Sponsors and Collaborators
Shanghai Golden Leaf MedTec Co. Ltd
Investigators
Layout table for investigator information
Study Chair: Gao-Jun Teng, MD Southeast University Affiliated Zhongda Hospital
Principal Investigator: zhong-Min Wang, MD Shanghai JiaoTong University Affiliated RuiJin Hospital
Principal Investigator: Jian Wang, MD Beijing University Affiliated the First Hospital
Principal Investigator: Wen-Tao Li, MD Fudan University Affiliated Cancer Hospital
Principal Investigator: Chuan-Sheng Zheng, MD HuaZhong University of Science and Technology Affiliated Union Hospital
Principal Investigator: Wei-Fu Lv, MD China University of Science and Technology Affiliated the First Hospital
Principal Investigator: Jun-Hui Sun, MD Zhejiang University Affiliated the First Hospital
Principal Investigator: Hao Xu, MD XuZhou Medical College Affiliated Hospital
Principal Investigator: Ming Huang, MD Yunnan Provincial Cancer Hospital
Principal Investigator: Li-Gong Lu, MD The People's Hospital of Zhuhai City
Principal Investigator: Jian-Song Ji, MD The Central Hospital of Lishui City
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Estimated Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Visual Analog Scale Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Morphine Equivalent Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]
    All analgesics used will be calculated to Morphine Equivalent using published conversion factors.
  • Quality of Life Score Changes over the time [ Time Frame: Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liver Cancer
  • Pancreas Cancer
  • Stomach Cancer
  • Bile Duct Cancer
Intervention  ICMJE Device: Endovascular Denervation
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.
Study Arms  ICMJE Experimental: Endovascular Denervation
Intervention: Device: Endovascular Denervation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2021
Estimated Primary Completion Date July 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hua Qing Yin, PhD 86-21-5486-8731 huaqing.yin@goldenleafmed.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014478
Other Study ID Numbers  ICMJE GL-CT-20161201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Shanghai Golden Leaf MedTec Co. Ltd
Study Sponsor  ICMJE Shanghai Golden Leaf MedTec Co. Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gao-Jun Teng, MD Southeast University Affiliated Zhongda Hospital
Principal Investigator: zhong-Min Wang, MD Shanghai JiaoTong University Affiliated RuiJin Hospital
Principal Investigator: Jian Wang, MD Beijing University Affiliated the First Hospital
Principal Investigator: Wen-Tao Li, MD Fudan University Affiliated Cancer Hospital
Principal Investigator: Chuan-Sheng Zheng, MD HuaZhong University of Science and Technology Affiliated Union Hospital
Principal Investigator: Wei-Fu Lv, MD China University of Science and Technology Affiliated the First Hospital
Principal Investigator: Jun-Hui Sun, MD Zhejiang University Affiliated the First Hospital
Principal Investigator: Hao Xu, MD XuZhou Medical College Affiliated Hospital
Principal Investigator: Ming Huang, MD Yunnan Provincial Cancer Hospital
Principal Investigator: Li-Gong Lu, MD The People's Hospital of Zhuhai City
Principal Investigator: Jian-Song Ji, MD The Central Hospital of Lishui City
PRS Account Shanghai Golden Leaf MedTec Co. Ltd
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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