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Endovascular Denervation in Patients With Cancer Pain

Primary Purpose

Cancer Pain

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

endovascular denervation

About this trial

This is an interventional treatment trial for Cancer Pain

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

25 to 75 years
severe cancer pain with the visual analogue scores of no less than 7

Exclusion Criteria:

pregnant or intent to become pregnant within 1 year
postural hypotension
uncorrected coagulation dysfunction
aortic aneurysm or dissection
type 1 diabetes mellitus (T1DM)
acute or severe systemic infection
history of cerebral apoplexy or transient ischemic attack (TIA) in the past two weeks
history of acute coronary syndrome in the past two weeks
participants who are not suitable to be enrolled into the study assessed by the researchers

Sites / Locations

Zhongda Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endovascular denervation

Arm Description

endovascular denervation

Outcomes

Primary Outcome Measures

Pain relief

Changes of the visual analogue scores (VAS) scores

Secondary Outcome Measures

Pain relief

Changes of the visual analogue scores (VAS) scores

Improvement of Quality of Life

Changes of the 100-item World Health Organization Quality of Life (QOL)

Incidence of Treatment Adverse Events

Assess artery damage, such as abdominal aortic dissection and abdominal aneurysm, by digital subtraction angiography or computed tomography

Full Information

NCT ID

NCT03431922

First Posted

January 19, 2018

Last Updated

February 6, 2018

Sponsor

Zhongda Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03431922

Brief Title

Endovascular Denervation in Patients With Cancer Pain

Official Title

Endovascular Denervation in Patients With Cancer Pain

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 21, 2017 (Actual)

Primary Completion Date

March 1, 2019 (Anticipated)

Study Completion Date

September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Endovascular arterial denervation (ED) is a minimally invasive technique which could reduce the occurrence of injury of visceral tissue or organs. As the principle of renal denervation (RDN), Radiofrequency energy delivered by a multi-electrode catheter to the celiac plexus over the anterolateral surface of the superior mesenteric artery (SMA) and the celiac axis. Damaged or partially damaged celiac plexus can achieve the effect of pain relief.

Detailed Description

The multi-electrode catheter was consisted of six independent electrodes helically on a net structure, which could be set as the same energy and temperature for simultaneous multi-point ablation. A real-time monitoring capability also provided by the display.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

endovascular denervation

Arm Type

Experimental

Arm Description

endovascular denervation

Intervention Type

Device

Intervention Name(s)

endovascular denervation

Intervention Description

multi-electrode catheter-based endovascular denervation

Primary Outcome Measure Information:

Title

Pain relief

Description

Changes of the visual analogue scores (VAS) scores

Time Frame

from baseline to 1 months after procedure

Secondary Outcome Measure Information:

Title

Pain relief

Description

Changes of the visual analogue scores (VAS) scores

Time Frame

from baseline to 3 months after procedure

Title

Improvement of Quality of Life

Description

Changes of the 100-item World Health Organization Quality of Life (QOL)

Time Frame

from baseline to 3 months after procedure

Title

Incidence of Treatment Adverse Events

Description

Assess artery damage, such as abdominal aortic dissection and abdominal aneurysm, by digital subtraction angiography or computed tomography

Time Frame

from baseline to 1 months after procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 25 to 75 years severe cancer pain with the visual analogue scores of no less than 7 Exclusion Criteria: pregnant or intent to become pregnant within 1 year postural hypotension uncorrected coagulation dysfunction aortic aneurysm or dissection type 1 diabetes mellitus (T1DM) acute or severe systemic infection history of cerebral apoplexy or transient ischemic attack (TIA) in the past two weeks history of acute coronary syndrome in the past two weeks participants who are not suitable to be enrolled into the study assessed by the researchers

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gao-Jun Teng, MD

Phone

+86 25 83272121

gjteng@seu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Qi Zhang, PhD

Phone

+86-15312027895

dnzhangqi@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gao-Jun Teng, MD

Organizational Affiliation

Zhongda Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongda Hospital, Southeast University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gao-Jun Teng, MD

Phone

+86 25 83272121

gjteng@seu.edu.cn

First Name & Middle Initial & Last Name & Degree

Qi Zhang, PhD

Phone

+86-15312027895

dnzhangqi@126.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15275792

Citation

de Oliveira R, dos Reis MP, Prado WA. The effects of early or late neurolytic sympathetic plexus block on the management of abdominal or pelvic cancer pain. Pain. 2004 Jul;110(1-2):400-8. doi: 10.1016/j.pain.2004.04.023.

Results Reference

background

PubMed Identifier

14996778

Citation

Wong GY, Schroeder DR, Carns PE, Wilson JL, Martin DP, Kinney MO, Mantilla CB, Warner DO. Effect of neurolytic celiac plexus block on pain relief, quality of life, and survival in patients with unresectable pancreatic cancer: a randomized controlled trial. JAMA. 2004 Mar 3;291(9):1092-9. doi: 10.1001/jama.291.9.1092.

Results Reference

background

PubMed Identifier

7508092

Citation

Cleeland CS, Gonin R, Hatfield AK, Edmonson JH, Blum RH, Stewart JA, Pandya KJ. Pain and its treatment in outpatients with metastatic cancer. N Engl J Med. 1994 Mar 3;330(9):592-6. doi: 10.1056/NEJM199403033300902.

Results Reference

background

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Endovascular Denervation in Patients With Cancer Pain

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