A Prospective Randomised Trial Comparing Radiofrequency Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism (WAVE)
Primary Aldosteronism
About this trial
This is an interventional treatment trial for Primary Aldosteronism focused on measuring ablation
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
Primary aldosteronism according to international guidelines11,14
1. An elevated ARR (according to local reference ranges), and at least one of (when measured off confounding medications):
- Spontaneous or thiazide-induced hypokalaemia, PAC >550pmol/L and PRA <0.5nmol/L/h or DRC <2.5pg/mL
- A positive saline infusion test (SIT)
- Four-hour aldosterone >190pmol/L 3. A positive captopril suppression test (CST), either:
- Failure to suppress two-hour aldosterone by >30% and persistent suppression of PRA/DRC11, or
- Two-hour aldosterone > 300 pmol/L14
Unilateral PA, defined by at least one of the following criteria:
1. ACTH-stimulated AVS24
- Selectivity index (SI) >3, and
- Lateralisation index (LI) > 4 2. Non-ACTH-stimulated AVS24
- SI > 2, and
- LI > 3, and
- Contralateral suppression index (CSI) < 0.5/1 3. Metomidate/CETO PET-CT25
- >25% higher PET signal (maximum standardised uptake value) over an adenoma compared to the contralateral adrenal 4. Age <35, unilateral adrenal lesion with normal contralateral gland11
Radiological abnormality ipsilateral to side of lateralisation, which is:
1. Benign:
- Unenhanced CT attenuation <20HU, or
- Post-contrast CT absolute washout >60%, or
- Post-contract CT relative washout >40%, or
- Signal drop-out on out-of-phase MRI 2. Technically amenable to both RFA and surgery (determined at MDT review)
- Able and willing to give informed consent
Exclusion Criteria:
Absolute contraindication to α- or β-adrenoceptor antagonist therapy or CT contrast, or
- Contraindication or unwillingness for either surgery or RFA, or
- Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks, or
- Unwilling to undergo either LA or RFA, or
- Unwilling to comply with study visit schedule, or
- Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only), or
- Life-limiting comorbidity (at the discretion of the PI)
- Clinical and/or biochemical evidence of autonomous cortisol secretion sufficient, in the opinion of the patient's physician, to mandate a unilateral adrenalectomy independent of autonomous aldosterone secretion
Sites / Locations
- St Bartholomew's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Radiofrequency ablation of adrenal aldosterone producing adenoma (s)
Unilateral adrenalectomy for aldosterone producing adenoma(s)
Ablation of adrenal aldosterone producing adenoma(s)
Unilateral adrenalectomy for laldosterone producing adenoma(s)