Haukeland University Hospital
In this study, the investigators will compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment in patients with primary aldosteronism (PA) with lateralisation of their aldosterone overproduction to their left adrenal and a left-sided tumour visible by EUS, with conventional unilateral adrenalectomy. The primary objective of the study is to evaluate biochemical and clinical outcome after EUS-RFA treatment compared with unilateral adrenalectomy. Secondary objectives are to compare safety/procedural complications of the two procedures, length of hospital stay, rate of postoperative hypoaldosteronism and hypocortisolism after treatment, and change health-related quality of life compared with pre-treatment.
Primary Aldosteronism
Aldosterone-Producing Adenoma
EUS-RFA of left adrenal gland
adrenalectomy
Not Applicable
Primary aldosteronism (PA) is the most common cause of secondary hypertension, and is associated with worse cardiovascular outcome than primary hypertension. Early diagnosis and treatment is paramount to avoid excess morbidity and death. The two main forms of PA are unilateral aldosterone-producing adenoma (APA), and bilateral idiopathic hyperaldosteronism (IHA). Differentiation between unilateral and bilateral disease determines treatment options. Adrenal vein sampling is the recommended procedure to determine PA subtype, unilateral or bilateral. For unilateral APAs, surgery with unilateral adrenalectomy is recommended treatment. Unilateral PA caused by an APA may also be treated with new, less invasive treatment modalities such as radiofrequency ablation (RFA), treating the APA only and sparing the remaining adrenal. The left adrenal is situated in near proximity to the stomach and is easily reached by endoscopic ultrasound (EUS), and may be targeted for RFA. In this study, EUS-RFA treatment in PA patients with adrenal vein sampling (AVS) lateralisation to the left adrenal and a visible adrenal tumour detected by EUS, will be compared with conventional unilateral adrenalectomy. Patients aged 18-60 years diagnosed with PA with AVS lateralisation to the left adrenal will be asked for study inclusion in the EUS-RFA group. If CT scan shows an adrenal nodule to the left adrenal, nodule size must be < 40 mm and enhancement value must fulfill criteria for a benign adenoma. Patients consenting to the EUS-RFA group will have a first EUS performed. If EUS of the left adrenal identifies an adrenal nodule, a fine needle tissue sampling will be performed for morphological and functional characterisation, including application of specific imaging mass cytometry for detection of aldosterone-producing cells. If the tumour tissue sampling confirms benign aldosterone-producing cells, a subsequent EUS-guided RFA procedure of the tumour will be performed. Patients not eligible for RFA treatment after the initial EUS will be treated with adrenalectomy. These patients will be included in an adrenalectomy control group, together with patients not consenting to EUS-RFA, and PA patients with lateralisation to the right adrenal, all performing adrenalectomy.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 40 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Treatment |
| Official Title : | Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism |
| Actual Study Start Date : | June 3, 2022 |
| Estimated Primary Completion Date : | December 31, 2028 |
| Estimated Study Completion Date : | December 31, 2028 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: EUS-RFA of left adrenal gland treatment group PA patients with AVS-confirmed lateralisation to the left adrenal and consent for EUS-RFA, will have a first EUS performed. If EUS identifies an adrenal nodule in the left adrenal, an EUS-guided fine needle tissue sampling will be performed of the adenoma/nodule and of adjacent non-adenoma adrenal tissue. If the tissue sampling confirms benign aldosterone-producing cells in the adenoma, a subsequent EUS-RFA treatment procedure will be performed. |
Procedure: EUS-RFA of left adrenal gland |
|
Active Comparator: Adrenalectomy control group Patients with AVS lateralisation to the left adrenal gland with EUS performed but no visible tumour found by EUS or EUS-guided tissue sampling not showing benign aldosterone-producing cells, therefore not suitable for RFA treatment, will be treated with conventional unilateral left adrenalectomy and will be included in an adrenalectomy control group. Patients with AVS lateralisation to the left adrenal but not consenting to EUS, and patients with AVS lateralisation to the right adrenal, will all likewise be treated with conventional unilateral adrenalectomy, and included in the adrenalectomy control group |
Procedure: adrenalectomy |
| Ages Eligible for Study: | 18 Years to 60 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Recruiting
Haukeland University Hospital
Bergen, Norway, 5021