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

Deirdre B. Fitzgerald; Calvin Sidhu; Charley Budgeon; Ai Ling Tan; Catherine A. Read; Benjamin C. H. Kwan; Nicola Ann Smith; Edward T. Fysh; Sanjeevan Muruganandan; Tajalli Saghaie; Ranjan Shrestha; Arash Badiei; Phan Nguyen; Andrew Burke; John Goddard; Morgan Windsor; Julie McDonald; Gavin Wright; Kasia Czarnecka; Parthipan Sivakumar; Kazuhiro Yasufuku; David J. Feller-Kopman; Nick A. Maskell; Kevin Murray; Y. C. Gary Lee

doi:10.1186/s13063-022-06405-7

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

Deirdre B. Fitzgerald, Calvin Sidhu, Charley Budgeon, Ai Ling Tan, Catherine A. Read, Benjamin C. H. Kwan, Nicola Ann Smith, Edward T. Fysh, Sanjeevan Muruganandan, Tajalli Saghaie, Ranjan Shrestha, Arash Badiei, Phan Nguyen, Andrew Burke, John Goddard, Morgan Windsor, Julie McDonald, Gavin Wright, Kasia Czarnecka, Parthipan SivakumarKazuhiro Yasufuku, David J. Feller-Kopman, Nick A. Maskell, Kevin Murray, Y. C. Gary Lee^*

^*Corresponding author for this work

Macquarie Medical School

Research output: Contribution to journal › Article › peer-review

15 Citations (Scopus)

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Abstract

Introduction: Malignant 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 analysis: A 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 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 scientific meetings. Discussion: Both 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 registration: Australia New Zealand Clinical Trial Registry ACTRN12618001013257. Registered on 18 June 2018. Protocol version: Version 3.00/4.02.19

Original language	English
Article number	530
Pages (from-to)	1-9
Number of pages	9
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06405-7
Publication status	Published - 27 Jun 2022

Bibliographical note

Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

Indwelling pleural catheter
Malignant
Pleural effusion
Randomised controlled trial
Video-assisted thoracoscopic surgery

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Fitzgerald, D. B., Sidhu, C., Budgeon, C., Tan, A. L., Read, C. A., Kwan, B. C. H., Smith, N. A., Fysh, E. T., Muruganandan, S., Saghaie, T., Shrestha, R., Badiei, A., Nguyen, P., Burke, A., Goddard, J., Windsor, M., McDonald, J., Wright, G., Czarnecka, K., ... Lee, Y. C. G. (2022). 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. Trials, 23(1), 1-9. Article 530. https://doi.org/10.1186/s13063-022-06405-7

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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",

abstract = "Introduction: Malignant 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 analysis: A 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 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 scientific meetings. Discussion: Both 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 registration: Australia New Zealand Clinical Trial Registry ACTRN12618001013257. Registered on 18 June 2018. Protocol version: Version 3.00/4.02.19",

keywords = "Indwelling pleural catheter, Malignant, Pleural effusion, Randomised controlled trial, Video-assisted thoracoscopic surgery",

author = "Fitzgerald, \{Deirdre B.\} and Calvin Sidhu and Charley Budgeon and Tan, \{Ai Ling\} and Read, \{Catherine A.\} and Kwan, \{Benjamin C. H.\} and Smith, \{Nicola Ann\} and Fysh, \{Edward T.\} and Sanjeevan Muruganandan and Tajalli Saghaie and Ranjan Shrestha and Arash Badiei and Phan Nguyen and Andrew Burke and John Goddard and Morgan Windsor and Julie McDonald and Gavin Wright and Kasia Czarnecka and Parthipan Sivakumar and Kazuhiro Yasufuku and Feller-Kopman, \{David J.\} and Maskell, \{Nick A.\} and Kevin Murray and Lee, \{Y. C. Gary\}",

note = "Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

year = "2022",

month = jun,

day = "27",

doi = "10.1186/s13063-022-06405-7",

language = "English",

volume = "23",

pages = "1--9",

journal = "Trials",

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Fitzgerald, DB, Sidhu, C, Budgeon, C, Tan, AL, Read, CA, Kwan, BCH, Smith, NA, Fysh, ET, Muruganandan, S, Saghaie, T, Shrestha, R, Badiei, A, Nguyen, P, Burke, A, Goddard, J, Windsor, M, McDonald, J, Wright, G, Czarnecka, K, Sivakumar, P, Yasufuku, K, Feller-Kopman, DJ, Maskell, NA, Murray, K & Lee, YCG 2022, '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', Trials, vol. 23, no. 1, 530, pp. 1-9. https://doi.org/10.1186/s13063-022-06405-7

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. / Fitzgerald, Deirdre B.; Sidhu, Calvin; Budgeon, Charley et al.
In: Trials, Vol. 23, No. 1, 530, 27.06.2022, p. 1-9.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Australasian Malignant PLeural Effusion (AMPLE)-3 trial

T2 - 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

AU - Fitzgerald, Deirdre B.

AU - Sidhu, Calvin

AU - Budgeon, Charley

AU - Tan, Ai Ling

AU - Read, Catherine A.

AU - Kwan, Benjamin C. H.

AU - Smith, Nicola Ann

AU - Fysh, Edward T.

AU - Muruganandan, Sanjeevan

AU - Saghaie, Tajalli

AU - Shrestha, Ranjan

AU - Badiei, Arash

AU - Nguyen, Phan

AU - Burke, Andrew

AU - Goddard, John

AU - Windsor, Morgan

AU - McDonald, Julie

AU - Wright, Gavin

AU - Czarnecka, Kasia

AU - Sivakumar, Parthipan

AU - Yasufuku, Kazuhiro

AU - Feller-Kopman, David J.

AU - Maskell, Nick A.

AU - Murray, Kevin

AU - Lee, Y. C. Gary

N1 - Copyright the Author(s) 2022. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2022/6/27

Y1 - 2022/6/27

N2 - Introduction: Malignant 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 analysis: A 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 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 scientific meetings. Discussion: Both 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 registration: Australia New Zealand Clinical Trial Registry ACTRN12618001013257. Registered on 18 June 2018. Protocol version: Version 3.00/4.02.19

AB - Introduction: Malignant 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 analysis: A 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 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 scientific meetings. Discussion: Both 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 registration: Australia New Zealand Clinical Trial Registry ACTRN12618001013257. Registered on 18 June 2018. Protocol version: Version 3.00/4.02.19

KW - Indwelling pleural catheter

KW - Malignant

KW - Pleural effusion

KW - Randomised controlled trial

KW - Video-assisted thoracoscopic surgery

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DO - 10.1186/s13063-022-06405-7

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AN - SCOPUS:85132953515

SN - 1745-6215

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Fitzgerald DB, Sidhu C, Budgeon C, Tan AL, Read CA, Kwan BCH et al. 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. Trials. 2022 Jun 27;23(1):1-9. 530. doi: 10.1186/s13063-022-06405-7

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

Abstract

Bibliographical note

Keywords

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