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Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

RecruitingNAAges 18 Years - 80 YearsAllHaukeland University Hospital
NCT05368090 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria all groups * Signed written informed consent * 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%) PA unilateral group inclusion criteria: * Age 18 to 60 years * PA diagnosis confirmed according to Endocrine Society PA Guideline criteria * AVS lateralisation to left adrenal (lateralisation index ≥ 4,0) PA "debulking" group inclusion criteria: * Age 18 to 70 years * PA diagnosis confirmed according to Endocrine Society PA Guideline criteria MACS unilateral and debulking group inclusion criteria: * 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 (debulking) Exclusion Criteria all groups: * CT scan suspicion of adrenal malignancy * Patient refusal to undergo either EUS-RFA or adrenalectomy
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What it tests

  • EUS-RFA of left adrenal tumour in PA with AVS-verified left lateralisation
  • EUS-RFA of left adrenal tumour in PA, "debulking group"
  • EUS-RFA of left adrenal tumour in MACS with AVS-verified left lateralisation
  • EUS-RFA of left adrenal tumour in MACS with bilateral overproduction, "debulking group
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Where

1 site
Haukeland University Hospital
Bergen, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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