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Completed

NCT Number: NCT00997594

Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

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

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Key information

Conditions

Adrenal Tumors Adrenal Gland Diseases Adrenal Gland Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mie University, Tsu, Mie-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

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.

Primary outcomes

  1. Increase in Catecholamine

    Time frame: One day

  2. Serum Cathecholamine Levels

    Time frame: around one year

  3. Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation

    Time frame: 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 outcomes

  1. Increase in Cortisol

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Mie University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2009
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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