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

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ClinicalTrials.gov Identifier: NCT04014478
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Golden Leaf MedTec Co. Ltd

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
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


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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014478


Contacts
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Contact: Hua Qing Yin, PhD 86-21-5486-8731 huaqing.yin@goldenleafmed.com

Sponsors and Collaborators
Shanghai Golden Leaf MedTec Co. Ltd
Investigators
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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

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Responsible Party: Shanghai Golden Leaf MedTec Co. Ltd
ClinicalTrials.gov Identifier: NCT04014478     History of Changes
Other Study ID Numbers: GL-CT-20161201
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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

Keywords provided by Shanghai Golden Leaf MedTec Co. Ltd:
Cancer; Pain

Additional relevant MeSH terms:
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Liver Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Pancreatic Neoplasms
Stomach Neoplasms
Cancer Pain
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Neoplasms
Bile Duct Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Gastrointestinal Neoplasms
Digestive System Diseases
Liver Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Biliary Tract Diseases
Adenocarcinoma
Carcinoma
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Stomach Diseases