Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHaukeland University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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%)
Age 18 to 60 years
PA diagnosis confirmed according to Endocrine Society PA Guideline criteria
Disqualifiers
CT scan suspicion of adrenal malignancy
Patient refusal to undergo either EUS-RFA or adrenalectomy
Trial design
Treatments tested in this trial
- 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
Treatment groups
60 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov