Australasian Malignant PLeural Effusion (AMPLE)-3 trial: study protocol for a multi-centre randomised study comparing indwelling pleural catheter (±talc pleurodesis) versus video-assisted thoracoscopic surgery for management of malignant pleural effusion

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dc.contributor.authorFitzgerald, D.B.
dc.contributor.authorSidhu, C.
dc.contributor.authorBudgeon, C.
dc.contributor.authorTan, A.L.
dc.contributor.authorRead, C.A.
dc.contributor.authorKwan, B.C.H.
dc.contributor.authorSmith, N.A.
dc.contributor.authorFysh, E.T.
dc.contributor.authorMuruganandan, S.
dc.contributor.authorSaghaie, T.
dc.contributor.authorShrestha, R.
dc.contributor.authorBadiei, A.
dc.contributor.authorNguyen, P.
dc.contributor.authorBurke, A.
dc.contributor.authorGoddard, J.
dc.contributor.authorWindsor, M.
dc.contributor.authorMcDonald, J.
dc.contributor.authorWright, G.
dc.contributor.authorCzarnecka, K.
dc.contributor.authorSivakumar, P.
dc.contributor.authoret al.
dc.date.issued2022
dc.description.abstractIntroduction: Malignant pleural efusions (MPEs) are common. MPE causes signifcant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-interven‑ tion rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instil‑ lation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-of intervention for MPE and is often recommended to patients who are ft for surgery. The AMPLE-3 trial is the frst randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are ft for surgery. Methods and analysis: A multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6months and good performance status randomised 1:1 to either IPC or VATS pleurodesis. Participant randomisation will be minimised for (i) cancer type (mesothelioma vs non-mesothelioma); (ii) previous pleurodesis (vs not); and (iii) trapped lung, if known (vs not). Primary outcome is the need for further ipsilateral pleural interventions over 12months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profle, health economics, adverse events, and survival. The trial will recruit 158 partici‑ pants who will be followed up for 12months. Ethics and dissemination: Sir Charles Gairdner and Osborne Park Health Care Group (HREC) has approved the study (reference: RGS356). Results will be published in peer-reviewed journals and presented at scientifc meetings. Discussion: Both IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help defne the merits and shortcomings of these procedures and inform future clinical care algorithms. Trial registration: Australia New Zealand Clinical Trial Registry ACTRN12618001013257. Registered on 18 June 2018. Protocol version: Version 3.00/4.02.19.
dc.description.statementofresponsibilityDeirdre B. Fitzgerald ... Arash Badiei ... Phan Nguyen ... et al.
dc.identifier.citationTrials, 2022; 23(1):530-1-530-9
dc.identifier.doi10.1186/s13063-022-06405-7
dc.identifier.issn1745-6215
dc.identifier.issn1745-6215
dc.identifier.orcidBadiei, A. [0000-0002-9237-8355]
dc.identifier.orcidNguyen, P. [0000-0002-8573-3574]
dc.identifier.urihttps://hdl.handle.net/2440/136620
dc.language.isoen
dc.publisherSpringer Nature
dc.relation.grantNHMRC
dc.rights© The Author(s) 2022. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
dc.source.urihttps://doi.org/10.1186/s13063-022-06405-7
dc.subjectPleural efusion; Indwelling pleural catheter; Malignant; Video-assisted thoracoscopic surgery; Randomised controlled trial
dc.subject.meshHumans
dc.subject.meshPleural Effusion, Malignant
dc.subject.meshTalc
dc.subject.meshThoracic Surgery, Video-Assisted
dc.subject.meshDrainage
dc.subject.meshPleurodesis
dc.subject.meshCatheters, Indwelling
dc.subject.meshQuality of Life
dc.subject.meshMulticenter Studies as Topic
dc.subject.meshRandomized Controlled Trials as Topic
dc.titleAustralasian Malignant PLeural Effusion (AMPLE)-3 trial: study protocol for a multi-centre randomised study comparing indwelling pleural catheter (±talc pleurodesis) versus video-assisted thoracoscopic surgery for management of malignant pleural effusion
dc.typeJournal article
pubs.publication-statusPublished

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