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Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

StatusRecruiting
PhaseNot applicable
Started2022-06-03
View on ClinicalTrials.gov ↗

Amendment history

2026-05-07
2 amendments v4-v5
2 re-verifications since 2024-11-07, no change to tracked fields
2024-04-24
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Enrollment target40→60
Study arms2→4
InterventionsEUS-RFA of left adrenal gland (Procedure), adrenalectomy (Procedure)→EUS-RFA of left adrenal tumour in MACS with AVS-verified left lateralisation (Procedure), EUS-RFA of left adrenal tumour in MACS with…
Eligibility criteria+254 characters
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 in [...] : Age 18 to 60 years Signed written informed consent PA diagnosis confirmed according to Endocrine Society PA Guideline criteria AVS lateralisation to oneleft adrenal (lateralisation index ≥ 4,0) IfPA CT"debulking" scangroup showsinclusion ancriteria: Age adrenal nodule18 to the70 [...]
Secondary endpointsdetails revised at 1 of 5 entries
Primary endpoints3 to 4 entries
Biochemical outcome in MACS after EUS-RFA compared with unilateral adrenalectomy Biochemical outcome in PA after EUS-RFA compared with unilateral adrenalectomy Clinical outcome in MACS after EUS-RFA Clinical comparedoutcome within unilateralPA adrenalectomyafter EUS-RFA
Study description+1,129 characters
[...] orbidity and death. The two main forms of PA are unilateral PA, often caused by an aldosterone-producing adenoma (APA), and bilateral idiopathic hyperaldosteronism (IHA)PA. Differentiation between unilateral and bilateral disease determines treatment options. Adrenal vein sampling (AVS) is the recommended procedure to determine PA subtype, unilateral or bilateral. For unilateral APAs,PA surgery with unilateral adrenalectomy is recommended treatment. UnilateralFor PA causedwithout byfulfilling lateralisation criteria, life-long medical treatment is recommended. Mild autonomous cortisol producti [...] [...]
Study sitescontacts updated at 1 of 1 site
2023-09-22
Study Status v2
Re-verified, no change to tracked fields
2022-08-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-06→confirmed 2022-06-03
Study sitesdetails revised at 1 of 1 site
2022-05-05
Original filing
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.
Trial Details
NCT Number NCT05368090
Lead Sponsor Haukeland University Hospital
Conditions Primary Aldosteronism, Aldosterone-Producing Adenoma, Hypercortisolism
Enrollment 60 participants
Start Date 2022-06-03
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-08