Endoscopic, ultrasound-guided, radiofrequency ablation of aldosterone-producing adenomas (FABULAS): a UK, multicentre, prospective, proof-of-concept trial.

Summary

In 28 participants undergoing 35 EUS-RFA sessions for left-sided APAs, no prespecified major hazards occurred. All PET-CT–positive nodules were targeted, with localized radiotracer reduction and 75% achieving complete or partial biochemical cure; 43% achieved clinical cure of hypertension at 6 months. Findings support EUS-RFA as a safe adrenal-sparing alternative to surgery for selected left-sided APAs.

Key Findings

• No prespecified major hazards (gastric/adrenal perforation, hemorrhage, organ infarction) occurred after EUS-RFA across 35 procedures.
• All PET-CT–positive nodules were successfully targeted and ablated, with localized reduction of radiotracer uptake at 3 months.
• Biochemical cure (complete or partial) achieved in 75% and clinical cure of hypertension in 43% at 6 months; some patients achieved normotension off medications.
• Technique provides an adrenal-sparing alternative to total adrenalectomy for left-sided APAs.

Clinical Implications

For patients with left-sided APA who are unwilling or unfit for AVS and adrenalectomy, EUS-RFA in expert centers may offer a safe alternative with meaningful biochemical and blood pressure improvements; however, randomized comparative studies and longer follow-up are needed before widespread adoption.

Limitations

• Non-randomized, single-arm feasibility with small sample size
• Limited to left-sided APAs near the stomach; generalizability to right-sided lesions unknown
• Short follow-up (3-month imaging, 6-month clinical) and some patients required two sessions

Future Directions

Conduct randomized trials comparing EUS-RFA versus adrenalectomy, extend to right-sided APAs, optimize energy dosing, and assess durability of biochemical and cardiovascular outcomes over years.