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The William Harvey Research Institute - Barts and The London

FABULAS

Feasibility study of radiofrequency endoscopic ablation, with ultrasound guidance, as a non-surgical, adrenal sparing treatment for aldosterone-producing adenomas.

Trial objective
The primary objective is to test our primary hypothesis which states that endoscopic ultrasound-guided radiofrequency ablation of aldosterone-producing adenomas of the adrenal gland is a safe method for achieving sustained reduction in plasma aldosterone.

The secondary objective is to evaluate the efficacy of Endoscopic Ultrasound ablation using biochemical and radiological measurements as follows:

  • Measurement of plasma electrolytes, renin and aldosterone at baseline, 1, 3 and 6 months following ablation.
  • PET CT will be performed at baseline and 3 months after ablation.
  • BP measurements in clinic at baseline, 1, 3 and 6 months following ablation.
  • Home BP measurements (3 readings morning and 3 in the evening) for 4 days before clinic visits recorded in patient blood pressure diary at 1, 3 and 6 months. 

Disease area
Cardiovascular 

Status
Open to recruitment

CI/PI
Prof. Stephen Pereira (CI)
Prof Morris Brown (PI)

Sponsor
University College London (UCL)

Funder
British Heart Foundation (BHF)

Study summary
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 begnin 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). Our 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.

Sample size and duration
30 patients. Minimum length of follow-up 6 months.

Enquiries  
Prof Morris Brown: morris.brown@qmul.ac.uk
Jackie Salsbury: j.salsbury@qmul.ac.uk
Patrizia Ebano: p.m.ebano@qmul.ac.uk