Radiofrequency Endoscopic Ablation With Ultrasound Guidance: a Non-surgical Treatment for Aldosterone-producing Adenomas (FABULAS)

 Adrenal Adenoma / Posted 3 weeks ago

High blood pressure (hypertension) causes strokes and heart attacks. While most patients need long-term treatment with pills, some have a cause which can be removed, curing the hypertension. The commonest curable cause is a benign nodule in one of the hormone glands, the adrenals. About one in 20 patients have such a nodule, but difficulties with diagnosis, and reluctance to proceed to surgery for a bengin condition, limit the number having adrenal gland surgery to fewer than 300 per year in the UK. A potential, and exciting, solution to this dilemma is to use a momentary electric current to cauterise the nodule (radiofrequency ablation), without affecting the rest of the adrenal gland, and avoiding the need for surgery. Nodules in the left adrenal gland are easily reached under mild sedation using a similar procedure as is standard for investigating stomach ulcers (endoscopy). The study is designed to show that this approach (endoscopic ultrasound guided radiofrequency ablation) is very safe, and to provide initial evidence that the hormone abnormality is cured.

  • Inclusion Criteria : Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No 1. Patients aged 18 and above 2. Diagnosis of PHA based on published Endocrine Society guidelines 3. Positive serum aldosterone renin ratio (ARR) with another local diagnostic confirmatory test (MRI or CT imaging) There are 3 inclusion subset groups: Group 1 1. Left-sided APA proven on either AVS or PET CT. 2. Patients wishing to take fewer drugs for their hypertension. 3. Patients not usually referred for surgery because the benefit: risk is considered too low. 4. Patients aged ≥60 whose BP is at or near target (BP140/90 for most patient groups, BP 130/80 if co-morbidities listed in Hypertension guidelines) on treatment with four or more drugs. 5. patients with identified macroadenomas (APAs >= 1 cm in diameter), who have at least 1 cm of peri-adrenal fat on axial and coronal projections. Group 2 Patients aged 18 years and above with diagnosis of PA and either: [i] a definite unilateral left APA, but the patient does not want surgery; or [ii] probable but not unequivocal evidence of a unilateral left adrenal APA. Group 3 Patients over 18 years of age meeting criteria for surgery, but consent to undergo endoscopic ablation instead.
  • Exclusion Criteria : 1. Inability to give informed consent. 2. Any patients continuing on beta blockers/direct renin blockers. 3. Pregnant women or those unable or unwilling to take secure contraceptive precautions. 4. Any illness, condition or drug regimen considered a contraindication by the PI/CI.
  • Study end date : 28/07/2022
  • Principal Investigator : Stephen Pereira +44 7918 030401
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