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

NCT04014478 | Unknown DMC

• 1 other identifier: GL-CT-20161201
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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

Keywords

Cancer； Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.

Secondary Outcomes (2)

• Morphine Equivalent Changes over the time

  Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.

• Quality of Life Score Changes over the time

  Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.

Study Arms (1)

Endovascular Denervation

EXPERIMENTAL

Device: Endovascular Denervation

Interventions

Endovascular Denervation 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.

Endovascular Denervation

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Golden Leaf MedTec Co. Ltd: lead

MeSH Terms

Conditions

Liver Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Bile Duct Neoplasms; Cancer Pain

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gao-Jun Teng, MD

  Zhongda Hospital

  STUDY CHAIR

• 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 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Qing Yin, PhD

CONTACT

86-21-5486-8731; huaqing.yin@goldenleafmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 10, 2019
• Study Start: July 15, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share