Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

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

Detailed Description
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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.

Official Title
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Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

Conditions
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Adrenal Tumors

Intervention / Treatment
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* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adrenal radiofrquency (RF) ablation<br>Patients who wll receive adrenal RF ablation. | Procedure: Radiofrequency ablation<br>* 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.<br>|
| Active Comparator: Abdominal RF ablation other than adrenal gland<br>Patients who will receive abdominal radiofrequency ablation other than adrenal gland. | Procedure: Radiofrequency ablation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Cortisol |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adrenal gland