{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T15:17:35Z","timestamp":1774538255167,"version":"3.50.1"},"reference-count":19,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T00:00:00Z","timestamp":1774483200000},"content-version":"unspecified","delay-in-days":25,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015652","name":"Barts Charity","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015652","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100023392","name":"NIHR Barts Biomedical Research Centre, Queen Mary University of London","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100023392","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,2,12]]},"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Unilateral aldosterone-producing adenomas (&gt;1\u2009cm) and aldosterone-producing nodules (&lt;1\u2009cm) 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u2009months. 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05405101\">NCT05405101<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-111798","type":"journal-article","created":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T14:20:41Z","timestamp":1774534841000},"page":"e111798","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"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"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct05405101","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05405101","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-0555-7071","authenticated-orcid":false,"given":"Kate","family":"Laycock","sequence":"first","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Kearney","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"},{"name":"Endocrinology ASO\/EASO COM, King\u2019s College Hospital NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yun-Ni","family":"Lee","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Macfarlane","sequence":"additional","affiliation":[{"name":"Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emily","family":"Goodchild","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisabeth","family":"Ng","sequence":"additional","affiliation":[{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonine","family":"Pineau Mitchell","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xilin","family":"Wu","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zin","family":"Htut","sequence":"additional","affiliation":[{"name":"Imperial College London, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"George","family":"Goodchild","sequence":"additional","affiliation":[{"name":"Gastroenterology, St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah","family":"Lowe","sequence":"additional","affiliation":[{"name":"The Royal London Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas","family":"Hilliard","sequence":"additional","affiliation":[{"name":"Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edmund","family":"Godfrey","sequence":"additional","affiliation":[{"name":"Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nad","family":"Qazi","sequence":"additional","affiliation":[{"name":"Imperial College London, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jose","family":"Bastos","sequence":"additional","affiliation":[{"name":"The Royal London Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aldons","family":"Chua","sequence":"additional","affiliation":[{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Razeen","family":"Mahroof","sequence":"additional","affiliation":[{"name":"Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"August","family":"Palma","sequence":"additional","affiliation":[{"name":"Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aklima","family":"Khatun","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chetna","family":"Varsani","sequence":"additional","affiliation":[{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniela","family":"Benu","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen P","family":"Pereira","sequence":"additional","affiliation":[{"name":"Institute for Liver and Digestive Health, University College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohan","family":"Krishnamurthy","sequence":"additional","affiliation":[{"name":"Nuclear Medicine, St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Heok","family":"Cheow","sequence":"additional","affiliation":[{"name":"Nuclear Medicine, Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teng-Teng","family":"Chung","sequence":"additional","affiliation":[{"name":"Endocrine, University College London, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Carroll","sequence":"additional","affiliation":[{"name":"Endocrine, Guy's and St Thomas\u2019 Hospitals NHS Trust, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samuel","family":"O\u2019Toole","sequence":"additional","affiliation":[{"name":"Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Florian","family":"Wernig","sequence":"additional","affiliation":[{"name":"Imperial College London, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Gurnell","sequence":"additional","affiliation":[{"name":"Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"Brown","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William M","family":"Drake","sequence":"additional","affiliation":[{"name":"Queen Mary University of London, London, UK"},{"name":"St Bartholomew\u2019s Hospital, London, England, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,3,26]]},"reference":[{"key":"2026032607201575000_16.3.e111798.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2006.07.059"},{"key":"2026032607201575000_16.3.e111798.2","doi-asserted-by":"publisher","DOI":"10.7326\/M20-0065"},{"key":"2026032607201575000_16.3.e111798.3","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1016\/S2213-8587(17)30367-4","article-title":"Cardiometabolic outcomes and mortality in medically treated primary aldosteronism: a retrospective cohort study","volume":"6","author":"Hundemer","year":"2018","journal-title":"Lancet Diabetes Endocrinol"},{"key":"2026032607201575000_16.3.e111798.4","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1016\/S2213-8587(17)30319-4","article-title":"Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis","volume":"6","author":"Monticone","year":"2018","journal-title":"Lancet Diabetes Endocrinol"},{"key":"2026032607201575000_16.3.e111798.5","doi-asserted-by":"crossref","first-page":"943","DOI":"10.1055\/s-0043-121706","article-title":"Health-Related Quality of Life and Mental Health in Primary Aldosteronism: A Systematic Review","volume":"49","author":"Velema","year":"2017","journal-title":"Horm Metab Res"},{"key":"2026032607201575000_16.3.e111798.6","doi-asserted-by":"crossref","first-page":"585","DOI":"10.1161\/HYPERTENSIONAHA.117.10596","article-title":"Adrenalectomy Lowers Incident Atrial Fibrillation in Primary Aldosteronism Patients at Long Term","volume":"71","author":"Rossi","year":"2018","journal-title":"Hypertension"},{"key":"2026032607201575000_16.3.e111798.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2019.08.017"},{"key":"2026032607201575000_16.3.e111798.8","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1210\/jc.2017-01442","article-title":"Quality of Life in Primary Aldosteronism: A Comparative Effectiveness Study of Adrenalectomy and Medical Treatment","volume":"103","author":"Velema","year":"2018","journal-title":"J Clin Endocrinol Metab"},{"key":"2026032607201575000_16.3.e111798.9","doi-asserted-by":"crossref","first-page":"689","DOI":"10.1016\/S2213-8587(17)30135-3","article-title":"Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort","volume":"5","author":"Williams","year":"2017","journal-title":"Lancet Diabetes Endocrinol"},{"key":"2026032607201575000_16.3.e111798.10","doi-asserted-by":"crossref","first-page":"1755","DOI":"10.1038\/s41416-022-01937-w","article-title":"Interpreting the results of noninferiority trials-a review","volume":"127","author":"Cuzick","year":"2022","journal-title":"Br J Cancer"},{"key":"2026032607201575000_16.3.e111798.11","doi-asserted-by":"publisher","DOI":"10.1097\/HJH.0000000000001961"},{"key":"2026032607201575000_16.3.e111798.12","first-page":"419","article-title":"The Freiburg Index of Patient Satisfaction: introduction and validation of a new questionnaire","volume":"137","author":"Schoenthaler","year":"2012","journal-title":"Dtsch Med Wochenschr"},{"key":"2026032607201575000_16.3.e111798.13","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgaa484"},{"key":"2026032607201575000_16.3.e111798.14","doi-asserted-by":"crossref","first-page":"637","DOI":"10.1016\/S0140-6736(24)02755-7","article-title":"Endoscopic, ultrasound-guided, radiofrequency ablation of aldosterone-producing adenomas (FABULAS): a UK, multicentre, prospective, proof-of-concept trial","volume":"405","author":"Argentesi","year":"2025","journal-title":"Lancet"},{"key":"2026032607201575000_16.3.e111798.15","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2015-4061"},{"key":"2026032607201575000_16.3.e111798.16","doi-asserted-by":"publisher","DOI":"10.1097\/HJH.0000000000002510"},{"key":"2026032607201575000_16.3.e111798.17","doi-asserted-by":"publisher","DOI":"10.1161\/HYPERTENSIONAHA.113.02097"},{"key":"2026032607201575000_16.3.e111798.18","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2011-1537"},{"key":"2026032607201575000_16.3.e111798.19","doi-asserted-by":"crossref","first-page":"336","DOI":"10.7326\/ANNALS-24-00761","article-title":"Molecular Imaging Versus Adrenal Vein Sampling for the Detection of Surgically Curable Primary Aldosteronism\u202f: A Prospective Within-Patient Trial","volume":"178","author":"Goodchild","year":"2025","journal-title":"Ann Intern Med"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2025-111798","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,26]],"date-time":"2026-03-26T14:20:44Z","timestamp":1774534844000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2025-111798"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":19,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,3,26]]},"published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1136\/bmjopen-2025-111798"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2025-111798","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]}}}