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

NCT ID: NCT04014478

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2021-07-15

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.

Conditions

Liver Cancer; Pancreas Cancer; Stomach Cancer; Bile Duct Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endovascular Denervation

Group Type: EXPERIMENTAL

Endovascular Denervation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Golden Leaf MedTec Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gao-Jun Teng, MD

Role: STUDY_CHAIR

Zhongda Hospital

zhong-Min Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai JiaoTong University Affiliated RuiJin Hospital

Jian Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing University Affiliated the First Hospital

Wen-Tao Li, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University Affiliated Cancer Hospital

Chuan-Sheng Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

HuaZhong University of Science and Technology Affiliated Union Hospital

Wei-Fu Lv, MD

Role: PRINCIPAL_INVESTIGATOR

China University of Science and Technology Affiliated the First Hospital

Jun-Hui Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University Affiliated the First Hospital

Hao Xu, MD

Role: PRINCIPAL_INVESTIGATOR

XuZhou Medical College Affiliated Hospital

Ming Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Yunnan Cancer Hospital

Li-Gong Lu, MD

Role: PRINCIPAL_INVESTIGATOR

The People's Hospital of Zhuhai City

Jian-Song Ji, MD

Role: PRINCIPAL_INVESTIGATOR

The Central Hospital of Lishui City

Central Contacts

Hua Qing Yin, PhD

Role: CONTACT

huaqing.yin@goldenleafmed.com

86-21-5486-8731

Other Identifiers

GL-CT-20161201

Identifier Type: -

Identifier Source: org_study_id