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Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Sponsor: Queen Mary University of London
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.
Official title: A Prospective Randomised Trial Comparing Thermal Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2022-09-01
Completion Date
2026-09-01
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Thermal 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.
Unilateral 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)
Locations (6)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, SMLG, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
University College London Hospital NHS Foundation Trust
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom