Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

NCT05368090 | Recruiting DMC

• 1 other identifier: 422376
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism; Aldosterone-Producing Adenoma; Hypercortisolism

Keywords

radio frequency ablation; postoperative hypoaldosteronism; postoperative hypocortisolism; metabolic comorbidity

Outcome Measures

Primary Outcomes (4)

• 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

  1 year

• Clinical outcome in PA after EUS-RFA

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

  1 year

• 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

  1 year

• 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

  1 year

Secondary Outcomes (5)

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

  3 months

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

  3 months

• Number of participants with postoperative hypoaldosteronism

  3 months

• Number of participants with postoperative hypocortisolism

  6 weeks

• Change from baseline in health-related quality of life at 1 year

  1 year

Study Arms (4)

EUS-RFA of PA with AVS-verified left lateralisation

EXPERIMENTAL

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.

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

EUS-RFA of PA without verified left lateralisation, for aldosterone "debulking"

EXPERIMENTAL

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.

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

EUS-RFA of MACS with left lateralisation and left adrenal tumour

EXPERIMENTAL

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.

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

EUS-RFA of MACS with bilateral cortisol overproduction and bilateral tumours

EXPERIMENTAL

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.

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

Interventions

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

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 PA with AVS-verified left lateralisation

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

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 PA without verified left lateralisation, for aldosterone "debulking"

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

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 MACS with left lateralisation and left adrenal tumour

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

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 MACS with bilateral cortisol overproduction and bilateral tumours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• AVS lateralisation to left adrenal (lateralisation index ≥ 4,0)
• Age 18 to 70 years
• PA diagnosis confirmed according to Endocrine Society PA Guideline 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)

You may not qualify if:

• CT scan suspicion of adrenal malignancy
• Patient refusal to undergo either EUS-RFA or adrenalectomy

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism; Adrenocortical Adenoma; Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Cortex Diseases

Study Officials

• Marianne Grytaas, MD phd

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Grytaas, MD phd

CONTACT

004741545435; marianne.grytaas@helse-bergen.no

Roald Havre, MD PhD

CONTACT

004790842938; roald.flesland.havre@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four EUS-RFA intervention study groups Group 1: PA with lateralisation to left adrenal and left-sided tumour for EUS-RFA Group 2: PA with suspected left-sided overweight of aldosterone overproduction but not AVS-verified left-sided lateralisation for EUS-RFA as "debulking" procedure Group 3: MACS with unilateral tumour in the left adrenal and unilateral cortisol overproduction verified by AVS, for EUS-RFA Group 4: MACS with bilateral adrenal tumours and AVS-verified bilateral cortisol overproduction for EUS-RFA as "debulking" procedure

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 10, 2022
• Study Start: June 3, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

NO (1)