Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism
Primary Aldosteronism, Aldosterone-Producing Adenoma
About this trial
This is an interventional treatment trial for Primary Aldosteronism focused on measuring radio frequency ablation, postoperative hypoaldosteronism, postoperative hypocortisolism
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 60 years
- Signed written informed consent
- PA diagnosis confirmed according to Endocrine Society PA Guideline criteria
- AVS lateralisation to one adrenal (lateralisation index ≥ 4,0)
- If CT scan shows an adrenal nodule to the same adrenal as AVS lateralisation result: nodule size < 4 cm and enhancement criteria for adrenal adenoma (native hounsfield units < 10 or relative wash-out > 40% or absolute wash-out > 60%)
- For EUS-RFA group: AVS lateralisation to the left adrenal only and EUS-guided tissue sampling of detected adrenal tumour for morphologic and functional characterisation confirming benign tumour tissue with aldosterone-producing cells
Exclusion Criteria:
- Age <18 or > 60 years
- CT scan or histological suspicion of adrenal malignancy
- Patient refusal to undergo either EUS-RFA or adrenalectomy
Sites / Locations
- Haukeland University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
EUS-RFA of left adrenal gland treatment group
Adrenalectomy control 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.
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