RecruitingNot ApplicableNCT05405101

Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

A Prospective Randomised Trial Comparing Thermal Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism

Sponsor

Queen Mary University of London

Enrollment

122 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Primary Aldosteronism

Summary

The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria. Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought. * Frequency and severity of adverse events * Length of inpatient stay * Patient satisfaction * Quality of life * Return to activities of daily living An additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

Age \> 18 years
Primary aldosteronism diagnosed according to international guidelines
Unilateral disease by AVS or PET-CT criteria
Ipsilateral radiological abnormality with benign imaging characteristics and technically amenable to both thermal ablation and surgery
Able and willing to give informed consent
Randomisation approved by MDT

Exclusion Criteria8

Absolute contraindication to α- or β-adrenoceptor antagonist therapy or CT contrast
Contraindication or unwillingness for either surgery or thermal ablation
Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks
Unwilling to undergo either LA or thermal ablation
Unwilling to comply with study visit schedule
Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only)
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

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Interventions

PROCEDUREThermal ablation of aldosterone producing adenoma.

On the left side, Radiofrequency ablation of aldosterone producing adenoma(s) will be undertaken via the stomach (endoscopically), under transgastric ultrasound guidance. On the right side, either Radiofrequency or Microwave Ablation of aldosterone producing adenoma(s) will be performed via a percutaneous approach, under CT guidance.

PROCEDUREUnilateral adrenalectomy

Unilateral total adrenalectomy for aldosterone producing adenoma. This will be laparoscopic in the vast majority of patients, with open conversion if surgically indicated (unlikely in \>1-2 patients)