Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

NCT ID: NCT00997594

Last Updated: 2015-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-10-31

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.

Conditions

Adrenal Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adrenal radiofrquency (RF) ablation

Patients who wll receive adrenal RF ablation.

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type: PROCEDURE

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.

Abdominal RF ablation other than adrenal gland

Patients who will receive abdominal radiofrequency ablation other than adrenal gland.

Group Type: ACTIVE_COMPARATOR

Radiofrequency ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mie University

OTHER

Sponsor Role: lead

Responsible Party

Koichiro Yamakado

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Koichiro Yamakado, MD

Role: STUDY_CHAIR

Mie University School of Medicine

Locations

Mie University Hospital

Tsu, Mie-ken, Japan

Mie University

Tsu, Mie-ken, Japan

Countries

Japan

Other Identifiers

No secondary IDs

Identifier Type: -

Identifier Source: secondary_id

274

Identifier Type: -

Identifier Source: org_study_id