BMJ open · 2026
Prospective randomised trial comparing thermal ablation With laparoscopic Adrenalectomy as an alternatiVE treatment for unilateral asymmetric primary aldosteronism: a protocol for the WAVE trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Laycock Kate, Kearney Jessica, Lee Yun-Ni, Macfarlane James, Goodchild Emily, Ng Elisabeth, Pineau Mitchell Antonine, Wu Xilin, Htut Zin, Goodchild George, Lowe Deborah, Hilliard Nicholas, Godfrey Edmund, Qazi Nad, Bastos Jose, Chua Aldons, Mahroof Razeen, Palma August, Khatun Aklima, Varsani Chetna, Benu Daniela, Pereira Stephen P, Krishnamurthy Mohan, Cheow Heok, Chung Teng-Teng, Carroll Paul, O'Toole Samuel, Wernig Florian, Gurnell Mark, Brown M, Drake William M
Аннотация
INTRODUCTION: 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.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: NCT05405101.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: NCT05405101.