NCT03431922

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

January 19, 2018

Last Update Submit

February 6, 2018

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    Changes of the visual analogue scores (VAS) scores

    from baseline to 1 months after procedure

Secondary Outcomes (3)

  • Pain relief

    from baseline to 3 months after procedure

  • Improvement of Quality of Life

    from baseline to 3 months after procedure

  • Incidence of Treatment Adverse Events

    from baseline to 1 months after procedure

Study Arms (1)

endovascular denervation

EXPERIMENTAL

endovascular denervation

Device: endovascular denervation

Interventions

endovascular denervationDEVICE

multi-electrode catheter-based endovascular denervation

endovascular denervation

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years
  • severe cancer pain with the visual analogue scores of no less than 7

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15275792BACKGROUND

  • 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.

    PMID: 14996778BACKGROUND

  • 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.

    PMID: 7508092BACKGROUND

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gao-Jun Teng, MD

    Zhongda Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, MD

CONTACT

+86 25 83272121gjteng@seu.edu.cn

Qi Zhang, PhD

CONTACT

+86-15312027895dnzhangqi@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 13, 2018

Study Start

September 21, 2017

Primary Completion

March 1, 2019

Study Completion

September 1, 2019

Last Updated

February 13, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)