Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Information source: Mie University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adrenal Tumors
Intervention: Radiofrequency ablation (Procedure)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Mie University Official(s) and/or principal investigator(s): Koichiro Yamakado, MD, Study Chair, Affiliation: Mie University School of Medicine
Summary
The purpose of this study is to evaluate changes in adrenal hormones during adrenal
radiofrequency (RF) ablation.
Clinical Details
Official title: Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Increase in CatecholamineSerum Cathecholamine Levels Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation
Secondary outcome: Increase in Cortisol
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
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Mie University, Tsu, Mie 514-8507, Japan
Mie University Hospital, Tsu, Mie 514-8507, Japan
Additional Information
Starting date: October 2009
Last updated: April 6, 2015
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