Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2019-05-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Aldosteronism Adrenal Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Radiofrequency ablation

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.

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type DEVICE

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.

Interventions

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Radiofrequency ablation

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No