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RECRUITING
NCT05405101
NA

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

Sponsor: Queen Mary University of London

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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