Actively Recruiting
Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism
Led by Haukeland University Hospital · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in patients with mild autonomous cortisol secretion (MACS). Four different study groups will all receive EUS-RFA of left-sided adrenal tumours. Clinical and biochemical outcome as well as procedural safety will be evaluated. In study patients with verified lateralised aldosterone or cortisol overproduction to the left adrenal, outcome will be compared with control groups performing conventional unilateral adrenalectomy. Study group 1: PA patients with AVS-verified left sided lateralisation and a EUS-detectable tumour in the left adrenal for EUS-RFA treatment. Study group 2: PA patient with suspected left-sided overweight of aldosterone production and a EUS-detectable tumour but without strict lateralisation of their aldosterone overproduction, for EUS-RFA treatment as an aldosterone "debulking" procedure. Study group 3: patients with MACS with AVS-verified lateralisation of cortisol overproduction to the left adrenal and EUS-detectable tumour for EUS-RFA treatment Study group 4: patients with MACS with bilateral adrenal tumours and verified bilateral overproduction of cortisol for EUS-RFA treatment as a cortisol "debulking" procedure.
CONDITIONS
Official Title
Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- If CT scan shows an adrenal nodule on the same adrenal as AVS lateralisation result: nodule size less than 4 cm and enhancement criteria for adrenal adenoma (native Hounsfield units less than 10 or relative wash-out more than 40% or absolute wash-out more than 60%)
- For primary aldosteronism (PA) unilateral group: age 18 to 60 years, PA diagnosis confirmed according to Endocrine Society PA Guideline criteria, AVS lateralisation to left adrenal (lateralisation index 243 4.0)
- For PA "debulking" group: age 18 to 70 years, PA diagnosis confirmed according to Endocrine Society PA Guideline criteria
- For mild autonomous cortisol secretion (MACS) unilateral and debulking groups: age 18 to 80 years, MACS diagnosis confirmed according to ENSAT/ECE Guideline criteria, AVS lateralisation to the left adrenal and visible left adrenal tumor on CT scan OR bilateral overproduction of cortisol on AVS and bilateral tumors/hyperplasia on CT scan
You will not qualify if you...
- CT scan suspicion of adrenal malignancy
- Patient refusal to undergo either EUS-RFA or adrenalectomy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Norway, 5021
Actively Recruiting
Research Team
M
Marianne Grytaas, MD phd
CONTACT
R
Roald Havre, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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