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Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997594
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : February 23, 2011
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):
Koichiro Yamakado, Mie University

Study Description
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Brief Summary:
The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.

Condition or disease Intervention/treatment Phase
Adrenal Tumors Procedure: Radiofrequency ablation Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Increase in Catecholamine [ Time Frame: One day ]
  2. Serum Cathecholamine Levels [ Time Frame: around one year ]
  3. Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation [ Time Frame: 1 week ]
    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 :
  1. Increase in Cortisol [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997594


Locations
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Japan
Mie University Hospital
Tsu, Mie, Japan, 514-8507
Mie University
Tsu, Mie, Japan, 514-8507
Sponsors and Collaborators
Mie University
Investigators
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Study Chair: Koichiro Yamakado, MD Mie University School of Medicine
More Information
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Responsible Party: Koichiro Yamakado, Clinical Professor, Mie University
ClinicalTrials.gov Identifier: NCT00997594    
Other Study ID Numbers: 274
No secondary IDs
First Posted: October 19, 2009    Key Record Dates
Results First Posted: February 23, 2011
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Koichiro Yamakado, Mie University:
adrenal gland
Additional relevant MeSH terms:
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Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
 Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases