Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Primary Purpose
Adrenal Tumors
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Adrenal Tumors focused on measuring adrenal gland
Eligibility 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
Sites / Locations
- Mie University Hospital
- Mie University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adrenal radiofrquency (RF) ablation
Abdominal RF ablation other than adrenal gland
Arm Description
Patients who wll receive adrenal RF ablation.
Patients who will receive abdominal radiofrequency ablation other than adrenal gland.
Outcomes
Primary Outcome Measures
Increase in Catecholamine
Serum Cathecholamine Levels
Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00997594
Brief Title
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Official Title
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mie University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Tumors
Keywords
adrenal gland
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adrenal radiofrquency (RF) ablation
Arm Type
Active Comparator
Arm Description
Patients who wll receive adrenal RF ablation.
Arm Title
Abdominal RF ablation other than adrenal gland
Arm Type
Active Comparator
Arm Description
Patients who will receive abdominal radiofrequency ablation other than adrenal gland.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase in Catecholamine
Time Frame
One day
Title
Serum Cathecholamine Levels
Time Frame
around one year
Title
Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Increase in Cortisol
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koichiro Yamakado, MD
Organizational Affiliation
Mie University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Mie University Hospital
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Mie University
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
12. IPD Sharing Statement
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Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
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