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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

IntroductionMalignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drain...

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Published in:Current controlled trials in cardiovascular medicine 2022-06, Vol.23 (1), p.530-530, Article 530
Main Authors: Fitzgerald, Deirdre B., Sidhu, Calvin, Budgeon, Charley, Tan, Ai Ling, Read, Catherine A., Kwan, Benjamin C. H., Smith, Nicola Ann, Fysh, Edward T., Muruganandan, Sanjeevan, Saghaie, Tajalli, Shrestha, Ranjan, Badiei, Arash, Nguyen, Phan, Burke, Andrew, Goddard, John, Windsor, Morgan, McDonald, Julie, Wright, Gavin, Czarnecka, Kasia, Sivakumar, Parthipan, Yasufuku, Kazuhiro, Feller-Kopman, David J., Maskell, Nick A., Murray, Kevin, Lee, Y. C. Gary
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cited_by cdi_FETCH-LOGICAL-c473t-8e00406087d315a110af498a451c7f8711901ae54405237aa32da2db397b27633
cites cdi_FETCH-LOGICAL-c473t-8e00406087d315a110af498a451c7f8711901ae54405237aa32da2db397b27633
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container_start_page 530
container_title Current controlled trials in cardiovascular medicine
container_volume 23
creator Fitzgerald, Deirdre B.
Sidhu, Calvin
Budgeon, Charley
Tan, Ai Ling
Read, Catherine A.
Kwan, Benjamin C. H.
Smith, Nicola Ann
Fysh, Edward T.
Muruganandan, Sanjeevan
Saghaie, Tajalli
Shrestha, Ranjan
Badiei, Arash
Nguyen, Phan
Burke, Andrew
Goddard, John
Windsor, Morgan
McDonald, Julie
Wright, Gavin
Czarnecka, Kasia
Sivakumar, Parthipan
Yasufuku, Kazuhiro
Feller-Kopman, David J.
Maskell, Nick A.
Murray, Kevin
Lee, Y. C. Gary
description IntroductionMalignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery.Methods and analysisA multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months 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 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months.Ethics and disseminationSir 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 scientific meetings.DiscussionBoth IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12618001013257. Registered on 18 June 2018.Protocol version: Version 3.00/4.02.19
doi_str_mv 10.1186/s13063-022-06405-7
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H. ; Smith, Nicola Ann ; Fysh, Edward T. ; Muruganandan, Sanjeevan ; Saghaie, Tajalli ; Shrestha, Ranjan ; Badiei, Arash ; Nguyen, Phan ; Burke, Andrew ; Goddard, John ; Windsor, Morgan ; McDonald, Julie ; Wright, Gavin ; Czarnecka, Kasia ; Sivakumar, Parthipan ; Yasufuku, Kazuhiro ; Feller-Kopman, David J. ; Maskell, Nick A. ; Murray, Kevin ; Lee, Y. C. Gary</creator><creatorcontrib>Fitzgerald, Deirdre B. ; Sidhu, Calvin ; Budgeon, Charley ; Tan, Ai Ling ; Read, Catherine A. ; Kwan, Benjamin C. H. ; Smith, Nicola Ann ; Fysh, Edward T. ; Muruganandan, Sanjeevan ; Saghaie, Tajalli ; Shrestha, Ranjan ; Badiei, Arash ; Nguyen, Phan ; Burke, Andrew ; Goddard, John ; Windsor, Morgan ; McDonald, Julie ; Wright, Gavin ; Czarnecka, Kasia ; Sivakumar, Parthipan ; Yasufuku, Kazuhiro ; Feller-Kopman, David J. ; Maskell, Nick A. ; Murray, Kevin ; Lee, Y. C. Gary</creatorcontrib><description>IntroductionMalignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery.Methods and analysisA multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months 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 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months.Ethics and disseminationSir 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 scientific meetings.DiscussionBoth IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12618001013257. 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Gary</creatorcontrib><title>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</title><title>Current controlled trials in cardiovascular medicine</title><description>IntroductionMalignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery.Methods and analysisA multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months 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 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months.Ethics and disseminationSir 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 scientific meetings.DiscussionBoth IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12618001013257. 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H.</au><au>Smith, Nicola Ann</au><au>Fysh, Edward T.</au><au>Muruganandan, Sanjeevan</au><au>Saghaie, Tajalli</au><au>Shrestha, Ranjan</au><au>Badiei, Arash</au><au>Nguyen, Phan</au><au>Burke, Andrew</au><au>Goddard, John</au><au>Windsor, Morgan</au><au>McDonald, Julie</au><au>Wright, Gavin</au><au>Czarnecka, Kasia</au><au>Sivakumar, Parthipan</au><au>Yasufuku, Kazuhiro</au><au>Feller-Kopman, David J.</au><au>Maskell, Nick A.</au><au>Murray, Kevin</au><au>Lee, Y. C. Gary</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><date>2022-06-27</date><risdate>2022</risdate><volume>23</volume><issue>1</issue><spage>530</spage><epage>530</epage><pages>530-530</pages><artnum>530</artnum><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>IntroductionMalignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery.Methods and analysisA multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months 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 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months.Ethics and disseminationSir 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 scientific meetings.DiscussionBoth IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12618001013257. Registered on 18 June 2018.Protocol version: Version 3.00/4.02.19</abstract><cop>London</cop><pub>BioMed Central</pub><pmid>35761341</pmid><doi>10.1186/s13063-022-06405-7</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0002-8668-1788</orcidid><oa>free_for_read</oa></addata></record>
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1745-6215
language eng
recordid cdi_doaj_primary_oai_doaj_org_article_d197bf0e95e24aeeb65efbdf08e3c8b2
source Open Access: PubMed Central; Publicly Available Content Database
subjects Cancer
Catheters
Consent
General anesthesia
Hospitals
Indwelling pleural catheter
Intervention
Malignant
Medical prognosis
Mesothelioma
Ostomy
Patients
Pleural effusion
Randomised controlled trial
Study Protocol
Success
Surgery
Video-assisted thoracoscopic surgery
title 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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