Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

Launched by HAUKELAND UNIVERSITY HOSPITAL · May 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for patients with primary aldosteronism (PA) or mild autonomous cortisol secretion (MACS). The trial will focus on patients who have left-sided adrenal tumors, which are small growths on the adrenal gland that can cause hormone imbalances. The goal is to see how effective and safe this treatment is compared to traditional surgery, known as unilateral adrenalectomy, which involves removing the affected adrenal gland.

To participate in the trial, you need to be between 18 and 80 years old and have a confirmed diagnosis of PA or MACS, along with specific test results showing that your tumor is on the left side. All participants will undergo the EUS-RFA procedure, which is less invasive than surgery, and researchers will monitor your health and hormone levels afterward. It's important to note that patients with certain conditions, such as suspected cancer in the adrenal gland, cannot participate. If you're interested, you’ll need to give your consent and meet the eligibility criteria. This trial aims to provide valuable information on a promising new treatment option for hormone-related conditions.

Gender

ALL

Eligibility criteria

• • 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