RecruitingNot Applicable

Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

Norway60 participantsStarted 2022-06-03

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Biochemical outcome in PA after EUS-RFA

Timeframe: 1 year

Clinical outcome in PA after EUS-RFA

Timeframe: 1 year

Biochemical outcome in MACS after EUS-RFA

Timeframe: 1 year

Clinical outcome in MACS after EUS-RFA

Timeframe: 1 year

Trial details

NCT IDNCT05368090

SponsorHaukeland University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Marianne Grytaas, MD phd

004741545435 marianne.grytaas@helse-bergen.no

View on ClinicalTrials.gov More Primary Aldosteronism trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.