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Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

ConditionsPrimary AldosteronismAldosterone-Producing AdenomaHypercortisolism
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • EUS-RFA of left adrenal tumour in PA with AVS-verified left lateralisation

    Procedure/Surgery

    Patients will fast, receive prophylactic antibiotics and conscious sedation prior to the endoscopic procedure.The procedure is performed with a standard linear echo-endoscope with a 3.7 mm or larger working channel. The left adrenal is identified from the fundus of the stomach. Color-Doppler is used to map adrenal vascularity. Ultrasound contrast is used to demarcate the border of the tumour. EUS-guided fine needle tissue sampling from tumour tissue is performed. The RFA ablation catheter is water-cooled and stable temperature is maintained at 70-75 degrees celsius until formation of heat bubbles can be seen on EUS. If necessary, the procedure is repeated after moving the probe until the whole adenoma volume is ablated. Ultrasound contrast medium is used after the procedure to ensure that the target for the ablation is non vascularized, before termination. The patients will be observed at the postoperative unit a few hours, and further in the ward for 24h

  • EUS-RFA of left adrenal tumour in PA, "debulking group"

    Procedure/Surgery

    Patients will fast, receive prophylactic antibiotics and conscious sedation prior to the endoscopic procedure.The procedure is performed with a standard linear echo-endoscope with a 3.7 mm or larger working channel. The left adrenal is identified from the fundus of the stomach. Color-Doppler is used to map adrenal vascularity. Ultrasound contrast is used to demarcate the border of the tumour. EUS-guided fine needle tissue sampling from tumour tissue is performed. The RFA ablation catheter is water-cooled and stable temperature is maintained at 70-75 degrees celsius until formation of heat bubbles can be seen on EUS. If necessary, the procedure is repeated after moving the probe until the whole adenoma volume is ablated. Ultrasound contrast medium is used after the procedure to ensure that the target for the ablation is non vascularized, before termination. The patients will be observed at the postoperative unit a few hours, and further in the ward for 24h

  • EUS-RFA of left adrenal tumour in MACS with AVS-verified left lateralisation

    Procedure/Surgery

    Patients will fast, receive prophylactic antibiotics and conscious sedation prior to the endoscopic procedure.The procedure is performed with a standard linear echo-endoscope with a 3.7 mm or larger working channel. The left adrenal is identified from the fundus of the stomach. Color-Doppler is used to map adrenal vascularity. Ultrasound contrast is used to demarcate the border of the tumour. EUS-guided fine needle tissue sampling from tumour tissue is performed. The RFA ablation catheter is water-cooled and stable temperature is maintained at 70-75 degrees celsius until formation of heat bubbles can be seen on EUS. If necessary, the procedure is repeated after moving the probe until the whole adenoma volume is ablated. Ultrasound contrast medium is used after the procedure to ensure that the target for the ablation is non vascularized, before termination. The patients will be observed at the postoperative unit a few hours, and further in the ward for 24h

  • EUS-RFA of left adrenal tumour in MACS with bilateral overproduction, "debulking group

    Procedure/Surgery

    Patients will fast, receive prophylactic antibiotics and conscious sedation prior to the endoscopic procedure.The procedure is performed with a standard linear echo-endoscope with a 3.7 mm or larger working channel. The left adrenal is identified from the fundus of the stomach. Color-Doppler is used to map adrenal vascularity. Ultrasound contrast is used to demarcate the border of the tumour. EUS-guided fine needle tissue sampling from tumour tissue is performed. The RFA ablation catheter is water-cooled and stable temperature is maintained at 70-75 degrees celsius until formation of heat bubbles can be seen on EUS. If necessary, the procedure is repeated after moving the probe until the whole adenoma volume is ablated. Ultrasound contrast medium is used after the procedure to ensure that the target for the ablation is non vascularized, before termination. The patients will be observed at the postoperative unit a few hours, and further in the ward for 24h

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: EUS-RFA of PA with AVS-verified left lateralisationExperimental treatment 1 intervention
Group B: EUS-RFA of PA without verified left lateralisation, for aldosterone "debulking"Experimental treatment 1 intervention
Group C: EUS-RFA of MACS with left lateralisation and left adrenal tumourExperimental treatment 1 intervention
Group D: EUS-RFA of MACS with bilateral cortisol overproduction and bilateral tumoursExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biochemical outcome in PA after EUS-RFA

Biochemical outcome will be evaluated by international standardised "Primary aldosteronism surgery outcome" (PASO) criteria at follow-up visits after 3 and 1 year

Time frame
1 year
2

Clinical outcome in PA after EUS-RFA

Clinical outcome will be evaluated by international standardised PASO criteria at follow-up visits after 1 year

Time frame
1 year
3

Biochemical outcome in MACS after EUS-RFA

Biochemical outcome will be evaluated at follow-up visits after 3 and 1 year, evaluated by the international European Network for Study of Adrenal Tumour (ENSAT) /European Society of Endocrinology (ESE) criteria

Time frame
1 year
4

Clinical outcome in MACS after EUS-RFA

Clinical outcome will be evaluated at follow-up visits after 3 and 1 year, evaluated by the international ENSAT/ESE criteria

Time frame
1 year

Secondary outcomes

1

Number of participants with procedural complications of EUS-RFA compared with unilateral adrenalectomy

Procedural complications of EUS-RFA compared with unilateral adrenalectomy will be performed using the Clavien-Dindo classification.

Time frame
3 months
2

Length of hospital stay after EUS-RFA compared with after adrenalectomy

Length of hospital stay after EUS-RFA will be compared with adrenalectomy, and will be evaluated at follow-up after 3 months

Time frame
3 months
3

Number of participants with postoperative hypoaldosteronism

Number of participants with postoperative hypoaldosteronism after EUS-RFA will be compared with unilateral adrenalectomy by biochemical assessment at 3 months after treatment

Time frame
3 months
4

Number of participants with postoperative hypocortisolism

Number of participants with postoperative hypocortisolism after EUS-RFA will be compared with unilateral adrenalectomy. In patients with an abnormal pre-treatment 1 mg dexamethasone suppression test or a low morning cortisol \< 300 nmol/L after RFA or adrenalectomy, individual advise of cortisone acetate replacement therapy will be given and an stimulation adrenocorticotropic hormone (ACTH) test will be performed in the Endocrinology Out-patient clinic \~ 6 weeks of discharge

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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Haukeland University Hospital

Lead sponsor

Source ClinicalTrials.gov
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