Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

Phase 2

Completed

• Conditions: Adrenal Tumors
• Interventions: Procedure: Radiofrequency ablation

• Registration Number: NCT00997594
• Lead Sponsor: Mie University

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2010-10-27
• Results First Submitted QC: 2011-01-27
• Results First Posted: 2011-02-23
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adrenal radiofrquency (RF) ablation	Radiofrequency ablation	Patients who wll receive adrenal RF ablation.
Abdominal RF ablation other than adrenal gland	Radiofrequency ablation	Patients who will receive abdominal radiofrequency ablation other than adrenal gland.

Primary Outcome Measures

Name	Time	Method
Increase in Catecholamine	One day
Serum Cathecholamine Levels	around one year
Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation	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

Name	Time	Method
Increase in Cortisol	1 day

Trial Locations

Locations (2)

Mie University Hospital; 🇯🇵 Tsu, Mie, Japan

Mie University; 🇯🇵 Tsu, Mie, Japan