{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,4]],"date-time":"2026-04-04T13:26:20Z","timestamp":1775309180284,"version":"3.50.1"},"reference-count":15,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Resp Res"],"published-print":{"date-parts":[[2017,11]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Malignant pleural effusion (MPE) is common and currently in UK there are an estimated 50 000 new cases of MPE per year. Talc pleurodesis remains one of the most popular methods for fluid control. The value of thoracic ultrasound (TUS) imaging, before and after pleurodesis, in improving the quality and efficacy of care for patients with MPE remains unknown. Additionally, biomarkers of successful pleurodesis including measurement of pleural fluid proteins have not been validated in prospective studies.<\/jats:p>\n                    <jats:p>The SIMPLE trial is an appropriately powered, multicentre, randomised controlled trial designed to assess \u2019by the patient bedside' use of TUS imaging and pleural fluid analysis in improving management of MPE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>262 participants with a confirmed MPE requiring intervention will be recruited from hospitals in UK and The Netherlands. Participants will be randomised (1:1) to undergo either chest drain insertion followed by instillation of sterile talc, or medical thoracoscopy and simultaneous poudrage. The allocated procedure will be done while the patient is hospitalised, and within 3 days of randomisation. Following hospital discharge, participants will be followed up at 1, 3 and 12 months. The primary outcome measure is the length of hospital stay during initial hospitalisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The trial has received ethical approval from the South Central-Oxford C Research Ethics Committee (Reference number 15\/SC\/0600). The Trial Steering Committee includes an independent chair and members, and a patient representative. The trial results will be published in a peer-reviewed journal and presented at international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ISRCTN:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"nct\" ext-link-type=\"clintrialgov\">NCT16441661<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjresp-2017-000225","type":"journal-article","created":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T16:55:43Z","timestamp":1761497743000},"page":"e000225","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE): protocol of a randomised controlled trial"],"prefix":"10.1136","volume":"4","clinical-trial-number":[{"clinical-trial-number":"nct16441661","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct16441661","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7284-0111","authenticated-orcid":false,"given":"Ioannis","family":"Psallidas","sequence":"first","affiliation":[{"name":"Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK"},{"name":"Nuffield Department of Medicine, Laboratory of Pleural and Lung Cancer Translational Research, University of Oxford, Oxford, UK"},{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"},{"name":"National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hania E G","family":"Piotrowska","sequence":"additional","affiliation":[{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ahmed","family":"Yousuf","sequence":"additional","affiliation":[{"name":"Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK"},{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikolaos I","family":"Kanellakis","sequence":"additional","affiliation":[{"name":"Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK"},{"name":"Nuffield Department of Medicine, Laboratory of Pleural and Lung Cancer Translational Research, University of Oxford, Oxford, UK"},{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"},{"name":"National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gayathri","family":"Kagithala","sequence":"additional","affiliation":[{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seid","family":"Mohammed","sequence":"additional","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lei","family":"Clifton","sequence":"additional","affiliation":[{"name":"Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Centre for Statistics in Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John P","family":"Corcoran","sequence":"additional","affiliation":[{"name":"Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK"},{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicky","family":"Russell","sequence":"additional","affiliation":[{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa","family":"Dobson","sequence":"additional","affiliation":[{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert F","family":"Miller","sequence":"additional","affiliation":[{"name":"Institute of Global Health, University College London, London, UK"},{"name":"Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Najib M","family":"Rahman","sequence":"additional","affiliation":[{"name":"Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK"},{"name":"Nuffield Department of Medicine, Laboratory of Pleural and Lung Cancer Translational Research, University of Oxford, Oxford, UK"},{"name":"Oxford Respiratory Trials Unit, Nuffield Department of Medicine, University of Oxford, Oxford, UK"},{"name":"National Institute for Health Research Oxford Biomedical Research Centre, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2017,11,20]]},"reference":[{"key":"2025102609455134000_4.1.e000225.1","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.162.5.ats8-00"},{"key":"2025102609455134000_4.1.e000225.2","doi-asserted-by":"publisher","DOI":"10.1378\/chest.116.1.266"},{"key":"2025102609455134000_4.1.e000225.3","unstructured":"Cr UK . Incidence of common cancers, 2005."},{"key":"2025102609455134000_4.1.e000225.4","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2010.136994"},{"key":"2025102609455134000_4.1.e000225.5","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(197404)33:4<916::AID-CNCR2820330405>3.0.CO;2-U"},{"key":"2025102609455134000_4.1.e000225.6","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.16840"},{"key":"2025102609455134000_4.1.e000225.7","unstructured":"Netten ADJ , Knight J . Unit Costs of Health and Social Care. PSSRU, 1999."},{"key":"2025102609455134000_4.1.e000225.8","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.97.10081907"},{"key":"2025102609455134000_4.1.e000225.9","doi-asserted-by":"publisher","DOI":"10.1378\/chest.103.4_Supplement.385S"},{"key":"2025102609455134000_4.1.e000225.10","doi-asserted-by":"publisher","DOI":"10.1136\/thx.49.1.23"},{"key":"2025102609455134000_4.1.e000225.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2006.06.004"},{"key":"2025102609455134000_4.1.e000225.12","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2010.137026"},{"key":"2025102609455134000_4.1.e000225.13","doi-asserted-by":"publisher","DOI":"10.1378\/chest.128.2.934"},{"key":"2025102609455134000_4.1.e000225.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejcts.2005.02.038"},{"key":"2025102609455134000_4.1.e000225.15","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2014-205285"}],"container-title":["BMJ Open Respiratory Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjresp-2017-000225","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T16:55:44Z","timestamp":1761497744000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopenrespres.bmj.com\/lookup\/doi\/10.1136\/bmjresp-2017-000225"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,11]]},"references-count":15,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2017,11,20]]},"published-print":{"date-parts":[[2017,11]]}},"alternative-id":["10.1136\/bmjresp-2017-000225"],"URL":"https:\/\/doi.org\/10.1136\/bmjresp-2017-000225","relation":{},"ISSN":["2052-4439"],"issn-type":[{"value":"2052-4439","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,11]]}}}