NCT05368090 Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism
| NCT ID | NCT05368090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Haukeland University Hospital |
| Condition | Primary Aldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-06-03 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-06-03 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Marianne Grytaas, MD phd
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT05368090 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05368090 currently recruiting?
Yes, NCT05368090 is actively recruiting participants. Contact the research team at marianne.grytaas@helse-bergen.no for enrollment information.
Where is the NCT05368090 trial being conducted?
This trial is being conducted at Bergen, Norway.
Who is sponsoring the NCT05368090 clinical trial?
NCT05368090 is sponsored by Haukeland University Hospital. The principal investigator is Marianne Grytaas, MD phd at Haukeland University Hospital. The trial plans to enroll 60 participants.