Endovascular Denervation in Patients With Cancer Pain

NCT ID: NCT03431922

Last Updated: 2018-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2019-09-01

Brief Summary

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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

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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.

Conditions

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Cancer Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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endovascular denervation

endovascular denervation

Group Type EXPERIMENTAL

endovascular denervation

Intervention Type DEVICE

multi-electrode catheter-based endovascular denervation

Interventions

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endovascular denervation

multi-electrode catheter-based endovascular denervation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao-jun Teng

Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gao-Jun Teng, MD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gao-Jun Teng, MD

Role: CONTACT

+86 25 83272121

Qi Zhang, PhD

Role: CONTACT

+86-15312027895

Facility Contacts

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Gao-Jun Teng, MD

Role: primary

+86 25 83272121

Qi Zhang, PhD

Role: backup

+86-15312027895

References

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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.

Reference Type BACKGROUND
PMID: 15275792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14996778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7508092 (View on PubMed)

Other Identifiers

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ED treatment

Identifier Type: -

Identifier Source: org_study_id

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