# Prospective randomised trial comparing thermal ablation With laparoscopic Adrenalectomy as an alternatiVE treatment for unilateral asymmetric primary aldosteronism: a protocol for the WAVE trial

## TL;DR

This study compares thermal ablation and laparoscopic adrenalectomy for treating adrenal tumors causing high blood pressure.

## Contribution

The WAVE trial introduces a randomized controlled trial protocol to evaluate thermal ablation as an alternative to surgery for primary aldosteronism.

## Key findings

- The WAVE trial will recruit 122 participants randomized in a 1.5:1 ratio to compare thermal ablation and laparoscopic adrenalectomy.
- Primary endpoints will assess biochemical and clinical outcomes at 6 months to determine non-inferiority of thermal ablation.
- Secondary outcomes include adverse events, hospital stay duration, patient satisfaction, and recovery time.

## Abstract

Unilateral aldosterone-producing adenomas (>1 cm) and aldosterone-producing nodules (<1 cm) are a common cause of primary aldosteronism (PA) and hypertension. Adrenal surgery can potentially cure or significantly improve the condition. However, fewer than 1% of patients with PA undergo adrenalectomy. For some, this is due to surgical risks, service capacity or patient preference against surgery. In these individuals, thermal ablation may provide an alternative. This paper describes the protocol for the WAVE trial, designed to compare thermal ablation with the current standard, laparoscopic adrenalectomy, in the treatment of unilateral PA.

WAVE is a prospective, multicentre, randomised controlled non-inferiority trial comparing thermal ablation (experimental arm) with laparoscopic adrenalectomy (control arm) in the treatment of unilateral PA. 122 participants will be recruited and randomised to thermal ablation or laparoscopic adrenalectomy in a 1.5:1 ratio. Hierarchical co-primary endpoint data considering both biochemical and clinical outcomes will be judged at 6 months. Secondary endpoint data will consider adverse events, length of inpatient stay, patient satisfaction and time to return to activities of daily living. The full protocol is available at ClinicalTrials.gov.

The protocol was approved by the Bloomsbury Research Ethics Committee (21/LO/0243). The results of the study will be shared with study participants, published in peer-reviewed journals and presented at national/international conferences.

NCT05405101.