Endoscopic ultrasound-guided radiofrequency ablation for adrenal tumors in primary aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) to treat left-sided adrenal tumors in patients with primary aldosteronism and mild autonomous cortisol secretion. Participants will be divided into groups based on their specific conditions and the presence of adrenal tumors, with outcomes evaluated against control groups undergoing traditional adrenalectomy. The study aims to assess both clinical and biochemical outcomes, as well as the safety of the EUS-RFA procedure. By targeting adrenal tumors non-invasively, the study seeks to provide an alternative treatment option for patients who may not qualify for surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Haukeland University Hospital
  Bergen, Norway Recruiting

Study contacts

• Principal investigator: Marianne Grytaas, MD phd — Haukeland University Hospital
• Study coordinator: Marianne Grytaas, MD phd
• Email: marianne.grytaas@helse-bergen.no
• Phone: 004741545435

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.