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临床试验/NCT02756754
NCT02756754已完成不适用

Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.

University Hospital, Toulouse3 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年11月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
3
主要终点
mean day-time systolic/diastolic blood pressure

研究概览

简要总结

The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. The safety of the procedure is one of the secondary outcomes.

详细描述

The prevalence of hypertension dramatically increased. Although most cases of hypertension are idiopathic, some cases have an identifiable cause. Primary Aldosteronism (PA) is the most common cause of secondary hypertension and can be cured by surgery if PA is due to unilateral unique adrenal adenoma. Then this cause is worth identifying it. The surgery despite its minimally invasive nature is limited by the need for general anesthesia, the risk of vascular or visceral injuries, hematomas and all the adrenal gland is mostly removed. Imaged-guided percutaneous adrenal radiofrequency ablation (ARF) offers a less invasive alternative therapeutic option. This local therapy is employed to treat solid neoplasms whereas its application on functional adrenal adenoma is less documented and only a few case series with limited sample size are published. The impact on blood pressure control is not clearly reported. ARF ablation works by delivering a high-frequency alternating current through a needle electrode. An ionic agitation occurs and generates frictional heat for cell destruction at a predictable temperature and volume. Patients with a conventional documented PA due to unilateral adrenal nod who consented to the study were hospitalized. Patients with PA due to an aldosterone-producing adenoma are included in the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • hypertension confirmed with ambulatory blood pressure monitoring
  • primary aldosteronism demonstrated by hormonal assays: active renin (pg/ml) or plasma renin activity (ng/ml/h) and plasma aldosterone measured twice at baseline after an overnight fast, in sitting or recumbent position
  • selective adrenal venous sampling after 40 years of age
  • unilateral adrenal nod on CT scan <4cm
  • adrenal radiofrequency ablation procedure of judged technically possible by radiologists

排除标准

  • bilateral adrenal nods
  • primary aldosteronism due to bilateral adrenal hyperplasia or macronodular hyperplasia
  • lack of documented primary aldosteronism
  • maximum tumor diameter greater than 4 cm
  • Cushing syndrome or Pheochromocytoma
  • when adrenal venous sampling is refused by the patient
  • coagulopathy
  • pregnant women
  • patient with potentially inaccessible nodule

研究组 & 干预措施

Radiofrequency ablation

Experimental

Radiofrequency ablation (RFA) is a minimally invasive technique for eliminating both primary tumors and metastases.

The needles that will be used are monopolar RFA, the LeVeen™ Needle Electrode Family with a generator "RF 3000" by Boston Scientific. The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored.

干预措施: Radiofrequency ablation (Device)

结局指标

主要结局

mean day-time systolic/diastolic blood pressure

时间窗: 6 months

mean day-time systolic/diastolic blood pressure \<135/85 mmHg at six months assessed by ambulatory blood pressure monitoring without antihypertensive treatment or a decrease of daytime systolic blood pressure of 20 mmHg and of diastolic blood pressure of 10 mmHg between baseline and 6 months

次要结局

  • mean day-time ambulatory blood pressure(6 months)
  • mean night-time ambulatory blood pressure(6 months)
  • mean 24 hour ambulatory blood pressure changes assessed by ambulatory blood pressure(6 months)
  • casual systolic blood pressure / diastolic blood pressure(6 months)
  • decrease of casual systolic blood pressure(6 months)
  • mean daytime ambulatory blood pressure changes assessed by self-measurement(6 months)
  • antihypertensive agents(6 months)
  • kalemia(6 months)
  • CT Scan(6 months)
  • day-time systolic and diastolic blood pressure(6 months)
  • mean 24 hours systolic/diastolic blood pressure(6 months)
  • post-operative complications(6 months)
  • cost-effectiveness(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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