Endovascular Denervation in Patients With Cancer Pain

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.

Study Overview

• Status: Unknown
• Conditions: Cancer Pain
• Intervention / Treatment: Device: endovascular denervation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gao-Jun Teng, MD; Phone Number: +86 25 83272121; Email: gjteng@seu.edu.cn
• Study Contact Backup: Name: Qi Zhang, PhD; Phone Number: +86-15312027895; Email: dnzhangqi@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital, Southeast University
      • Contact: Gao-Jun Teng, MD; Phone Number: +86 25 83272121; Email: gjteng@seu.edu.cn
      • Contact: Qi Zhang, PhD; Phone Number: +86-15312027895; Email: dnzhangqi@126.com

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endovascular denervation	Device: endovascular denervation; multi-electrode catheter-based endovascular denervation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Changes of the visual analogue scores (VAS) scores	from baseline to 1 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain relief	Changes of the visual analogue scores (VAS) scores	from baseline to 3 months after procedure
Improvement of Quality of Life	Changes of the 100-item World Health Organization Quality of Life (QOL)	from baseline to 3 months after procedure
Incidence of Treatment Adverse Events	Assess artery damage, such as abdominal aortic dissection and abdominal aneurysm, by digital subtraction angiography or computed tomography	from baseline to 1 months after procedure

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-Jun Teng, MD, Zhongda Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: ED treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No