Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

Adrenal Tumors Clinical Trial

Official title:

Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997594
• Other study ID #: 274
• Secondary ID: No secondary IDs
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 16, 2009
• Last updated: April 6, 2015
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2015
• Source: Mie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Tumors

Intervention

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.

Locations

Country	Name	City	State
Japan	Mie University	Tsu	Mie
Japan	Mie University Hospital	Tsu	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Mie University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in Catecholamine		One day	No
Primary	Serum Cathecholamine Levels		around one year	No
Primary	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	Yes
Secondary	Increase in Cortisol		1 day	No