Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

April 6, 2015 updated by: Koichiro Yamakado, Mie University
The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Mie University Hospital
      • Tsu, Mie, Japan, 514-8507
        • Mie University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in Catecholamine
Time Frame: One day
One day
Serum Cathecholamine Levels
Time Frame: around one year
around one year
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.
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in Cortisol
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mie University

Investigators

  • Study Chair: Koichiro Yamakado, MD, Mie University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274
  • No secondary IDs

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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