{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Kate Laycock"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK",
        "Endocrinology ASO/EASO COM, King’s College Hospital NHS Trust, London, UK"
      ],
      "name": "Jessica Kearney"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Yun-Ni Lee"
    },
    {
      "affiliations": [
        "Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"
      ],
      "name": "James Macfarlane"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Emily Goodchild"
    },
    {
      "affiliations": [
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Elisabeth Ng"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Antonine Pineau Mitchell"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Xilin Wu"
    },
    {
      "affiliations": [
        "Imperial College London, London, England, UK"
      ],
      "name": "Zin Htut"
    },
    {
      "affiliations": [
        "Gastroenterology, St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "George Goodchild"
    },
    {
      "affiliations": [
        "The Royal London Hospital, London, England, UK"
      ],
      "name": "Deborah Lowe"
    },
    {
      "affiliations": [
        "Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"
      ],
      "name": "Nicholas Hilliard"
    },
    {
      "affiliations": [
        "Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"
      ],
      "name": "Edmund Godfrey"
    },
    {
      "affiliations": [
        "Imperial College London, London, England, UK"
      ],
      "name": "Nad Qazi"
    },
    {
      "affiliations": [
        "The Royal London Hospital, London, England, UK"
      ],
      "name": "Jose Bastos"
    },
    {
      "affiliations": [
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Aldons Chua"
    },
    {
      "affiliations": [
        "Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"
      ],
      "name": "Razeen Mahroof"
    },
    {
      "affiliations": [
        "Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"
      ],
      "name": "August Palma"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Aklima Khatun"
    },
    {
      "affiliations": [
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Chetna Varsani"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Daniela Benu"
    },
    {
      "affiliations": [
        "Institute for Liver and Digestive Health, University College London, London, UK"
      ],
      "name": "Stephen P Pereira"
    },
    {
      "affiliations": [
        "Nuclear Medicine, St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "Mohan Krishnamurthy"
    },
    {
      "affiliations": [
        "Nuclear Medicine, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"
      ],
      "name": "Heok Cheow"
    },
    {
      "affiliations": [
        "Endocrine, University College London, London, England, UK"
      ],
      "name": "Teng-Teng Chung"
    },
    {
      "affiliations": [
        "Endocrine, Guy's and St Thomas’ Hospitals NHS Trust, London, England, UK"
      ],
      "name": "Paul Carroll"
    },
    {
      "affiliations": [
        "Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England, UK"
      ],
      "name": "Samuel O’Toole"
    },
    {
      "affiliations": [
        "Imperial College London, London, England, UK"
      ],
      "name": "Florian Wernig"
    },
    {
      "affiliations": [
        "Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"
      ],
      "name": "Mark Gurnell"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "M Brown"
    },
    {
      "affiliations": [
        "Queen Mary University of London, London, UK",
        "St Bartholomew’s Hospital, London, England, UK"
      ],
      "name": "William M Drake"
    }
  ],
  "title": "Prospective randomised trial comparing thermal ablation With laparoscopic Adrenalectomy as an alternatiVE treatment for unilateral asymmetric primary aldosteronism: a protocol for the WAVE trial",
  "uid": "8c7fea78-f051-5e82-94b6-fad43613fd84"
}