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

NCT04014478 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-07-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shanghai Golden Leaf MedTec Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Gao-Jun Teng, MD · Zhongda Hospital

  • zhong-Min Wang, MD · Shanghai JiaoTong University Affiliated RuiJin Hospital

  • Jian Wang, MD · Beijing University Affiliated the First Hospital

  • Wen-Tao Li, MD · Fudan University Affiliated Cancer Hospital

  • Chuan-Sheng Zheng, MD · HuaZhong University of Science and Technology Affiliated Union Hospital

  • Wei-Fu Lv, MD · China University of Science and Technology Affiliated the First Hospital

  • Jun-Hui Sun, MD · Zhejiang University Affiliated the First Hospital

  • Hao Xu, MD · XuZhou Medical College Affiliated Hospital

  • Ming Huang, MD · Yunnan Cancer Hospital

  • Li-Gong Lu, MD · The People's Hospital of Zhuhai City

  • Jian-Song Ji, MD · The Central Hospital of Lishui City

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2021-07-15
Completion
2021-07-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04014478 on ClinicalTrials.gov