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

July 8, 2019 updated by: Shanghai Golden Leaf MedTec Co. Ltd

A Prospective, Multicenter, Self-Control Clinical Trial to Evaluate Safety and Efficacy of Endovascular Denervation in Treatment of Cancer Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.
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.
Pre-treatment; 1, 3, 15, 30, 60, and 90 days after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Golden Leaf MedTec Co. Ltd

Investigators

  • Study Chair: Gao-Jun Teng, MD, 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 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 15, 2019

Primary Completion (ANTICIPATED)

July 15, 2021

Study Completion (ANTICIPATED)

July 15, 2021

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (ACTUAL)

July 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GL-CT-20161201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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