Clinical trial NCT03431922: Endovascular Denervation in Patients With Cancer Pain
Official title: Endovascular Denervation in Patients With Cancer Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Pain
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain relief
timeFrame: from baseline to 1 months after procedure
Secondary outcomes:
measure: Pain relief
timeFrame: from baseline to 3 months after procedure
measure: Improvement of Quality of Life
timeFrame: from baseline to 3 months after procedure
measure: Incidence of Treatment Adverse Events
timeFrame: from baseline to 1 months after procedure
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.