Endoscopic Ultrasound-guided Radiofrequency Ablation as a Novel Treatment Option Compared With Adrenalectomy in Left-sided Primary Aldosteronism

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
Contact Information
Primary
Marianne Grytaas, MD phd
marianne.grytaas@helse-bergen.no
004741545435
Backup
Roald Havre, MD PhD
roald.flesland.havre@helse-bergen.no
004790842938
Time Frame
Start Date: 2022-06-03
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 60
Treatments
Experimental: EUS-RFA of PA with AVS-verified left lateralisation
PA patients with AVS-confirmed lateralisation to the left adrenal and signed study consent will be included in this study group. EUS will be performed. If EUS identifies an adrenal nodule in the left adrenal, EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure will be performed. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.
Experimental: EUS-RFA of PA without verified left lateralisation, for aldosterone debulking
PA patients with suspicion of aldosterone overproduction in their left adrenal, but without fulfilling the strict AVS lateralization criteria, either due to a non-representative AVS, or a representative AVS but without significant left-sided lateralization (LI \< 4), and where the study investigators consider EUS-RFA treatment as an aldosterone-reducing procedure to be of high potential clinical and biochemical benefit for the patient, will be included in this study group after signed consent. EUS will be performed. If EUS identifies an adrenal nodule in the left adrenal, an EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.
Experimental: EUS-RFA of MACS with left lateralisation and left adrenal tumour
MACS patients with AVS-confirmed lateralisation the left adrenal gland and CT showing left-sided tumour will be included in this study group after signed consent. EUS will be performed, and a EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.
Experimental: EUS-RFA of MACS with bilateral cortisol overproduction and bilateral tumours
MACS patients with AVS-confirmed bilateral cortisol overproduction and bilateral tumours will be included in this study group after signed study consent. EUS will be performed, and EUS-guided fine needle tissue sampling of the adenoma will be performed, before a subsequent EUS-RFA treatment procedure. Follow-up after 2 weeks, 3 months and 12 months for evaluation of clinical and biochemical outcome, and procedural complications.
Related Therapeutic Areas
Sponsors
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov