Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
This study has been completed.
Sponsor:
Mie University
Information provided by:
Mie University
ClinicalTrials.gov Identifier:
NCT00997594
First received: October 16, 2009
Last updated: March 21, 2011
Last verified: October 2010
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Purpose
The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.
| Condition | Intervention | Phase |
|---|---|---|
|
Adrenal Gland Neoplasms |
Procedure: Radiofrequency ablation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation |
Resource links provided by NLM:
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Racepinephrine hydrochloride
Racepinephrine
U.S. FDA Resources
Further study details as provided by Mie University:
Primary Outcome Measures:
- Increase in Catecholamine [ Time Frame: One day ] [ Designated as safety issue: No ]
- Serum Cathecholamine Levels [ Time Frame: around one year ] [ Designated as safety issue: No ]
- Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]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:
- Increase in Cortisol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | October 2009 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Adrenal radiofrquency (RF) ablation
Patients who wll receive adrenal RF ablation.
|
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.
|
|
Active Comparator: Abdominal RF ablation other than adrenal gland
Patients who will receive abdominal radiofrequency ablation other than adrenal gland.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997594
Locations
| Japan | |
| Mie University Hospital | |
| Tsu, Mie, Japan, 514-8507 | |
| Mie University | |
| Tsu, Mie, Japan, 514-8507 | |
Sponsors and Collaborators
Mie University
Investigators
| Study Chair: | Koichiro Yamakado, MD | Mie University School of Medicine |
More Information
No publications provided
| Responsible Party: | Department of Radiology, Mie University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00997594 History of Changes |
| Other Study ID Numbers: | 274, No secondary IDs |
| Study First Received: | October 16, 2009 |
| Results First Received: | October 27, 2010 |
| Last Updated: | March 21, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Mie University:
|
adrenal gland |
Additional relevant MeSH terms:
|
Adrenal Gland Neoplasms Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Gland Diseases Endocrine System Diseases Epinephrine Epinephryl borate Hormones Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013