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临床试验/NCT00997594
NCT00997594已完成2 期

Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation

Mie University4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
18
试验地点
4
主要终点
Increase in Catecholamine

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Platelet count of 50,000/mm^3 or International normalized ratio (INR)>1.5

结局指标

主要结局

Increase in Catecholamine

时间窗: One day

Serum Cathecholamine Levels

时间窗: around one year

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

时间窗: 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.

次要结局

  • Increase in Cortisol(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Koichiro Yamakado

Clinical Professor

Mie University

研究点 (4)

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