Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

This study has been completed.
Sponsor:
Information provided by:
Mie University
ClinicalTrials.gov Identifier:
NCT00997594
First received: October 16, 2009
Last updated: March 21, 2011
Last verified: October 2010
  Purpose

The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.


Condition Intervention Phase
Adrenal Gland Neoplasms
Procedure: Radiofrequency ablation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

Resource links provided by NLM:


Further study details as provided by Mie University:

Primary Outcome Measures:
  • Increase in Catecholamine [ Time Frame: One day ] [ Designated as safety issue: No ]
  • Serum Cathecholamine Levels [ Time Frame: around one year ] [ Designated as safety issue: No ]
  • Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups.


Secondary Outcome Measures:
  • Increase in Cortisol [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2009
Arms Assigned Interventions
Active Comparator: Adrenal radiofrquency (RF) ablation
Patients who wll receive adrenal RF ablation.
Procedure: Radiofrequency ablation
Radiofrequency (RF) ablation was done after RF electrodes were placed in the adrenal tumor in the adrenal RF ablation group. RF ablation was done after RF electrodes were placed in the targeted abdominal tumors other than adrenal gland in the abdominal RF ablation other than adrenal gland group.
Active Comparator: Abdominal RF ablation other than adrenal gland
Patients who will receive abdominal radiofrequency ablation other than adrenal gland.
Procedure: Radiofrequency ablation
Radiofrequency (RF) ablation was done after RF electrodes were placed in the adrenal tumor in the adrenal RF ablation group. RF ablation was done after RF electrodes were placed in the targeted abdominal tumors other than adrenal gland in the abdominal RF ablation other than adrenal gland group.

Detailed Description:

Adrenal radiofrequency (RF) ablation has been increasingly used for the treatment of unresectable adrenal tumors. But one of the major complication is a increase in blood pressure. Hormonal release during RF ablation is considered the cause of hypertension. But there has been no evidence that adrenal hormones affects changes in blood pressure. In this prospective study, we evaluate the changes in adrenal hormones during RF ablation and clarify the cause of hypertensive crisis.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unresectable adrenal tumor which will be treated by radiofrequency (RF)ablation
  • Blood pressure is 140mmHg or less before RF ablation
  • Age of 20-years or more
  • Performance status of 0 or 1
  • Agreement from the patient

Exclusion Criteria:

  • Platelet count of 50,000/mm^3 or International normalized ratio (INR)>1.5
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997594

Locations
Japan
Mie University
Tsu, Mie, Japan, 514-8507
Mie University Hospital
Tsu, Mie, Japan, 514-8507
Sponsors and Collaborators
Mie University
Investigators
Study Chair: Koichiro Yamakado, MD Mie University School of Medicine
  More Information

No publications provided

Responsible Party: Department of Radiology, Mie University School of Medicine
ClinicalTrials.gov Identifier: NCT00997594     History of Changes
Other Study ID Numbers: 274, No secondary IDs
Study First Received: October 16, 2009
Results First Received: October 27, 2010
Last Updated: March 21, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mie University:
adrenal gland

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Adrenal Gland Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Epinephrine
Epinephryl borate
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 23, 2014