Endovascular Denervation in Patients With Cancer Pain

Cancer Pain Clinical Trial

Official title:

Endovascular Denervation in Patients With Cancer Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03431922
• Other study ID #: ED treatment
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2018
• Last updated: February 6, 2018
• Start date: September 21, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: February 2018
• Source: Zhongda Hospital
• Contact: Gao-Jun Teng, MD
• Phone: +86 25 83272121
• Email: gjteng[@]seu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Device:
• endovascular denervation
multi-electrode catheter-based endovascular denervation

Locations

Country	Name	City	State
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Changes of the visual analogue scores (VAS) scores	from baseline to 1 months after procedure
Secondary	Pain relief	Changes of the visual analogue scores (VAS) scores	from baseline to 3 months after procedure
Secondary	Improvement of Quality of Life	Changes of the 100-item World Health Organization Quality of Life (QOL)	from baseline to 3 months after procedure
Secondary	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