Endovascular Denervation in Patients With Cancer Pain

Not Applicable

• Conditions: Cancer Pain
• Interventions: Device: endovascular denervation

• Registration Number: NCT03431922
• Lead Sponsor: Zhongda Hospital

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.

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2018-01-19
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-06
• Last Update Submitted: 2018-02-06
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13
• Primary Completion: 2019-03-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endovascular denervation	endovascular denervation	endovascular denervation

Primary Outcome Measures

Name	Time	Method
Pain relief	from baseline to 1 months after procedure	Changes of the visual analogue scores (VAS) scores

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongda Hospital, Southeast University; 🇨🇳 Nanjing, Jiangsu, China