Protocol of the Australasian Malignant Pleural Effusion-2 (AMPLE-2) trial: A multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters

Maree Azzopardi, Rajesh Thomas, Sanjeevan Muruganandan, David C L Lam, Luke A. Garske, Benjamin C H Kwan, Muhammad Redzwan S Rashid Ali, Phan T. Nguyen, Elaine Yap, Fiona C. Horwood, Alexander J. Ritchie, Michael Bint, Claire L. Tobin, Ranjan Shrestha, Francesco Piccolo, Christian C. De Chaneet, Jenette Creaney, Robert U. Newton, Delia Hendrie, Kevin MurrayCatherine A. Read, David Feller-Kopman, Nick A. Maskell, Y. C. Gary Lee

Research output: Contribution to journalArticle

Abstract

Introduction Malignant pleural effusions (MPEs) can complicate most cancers, causing dyspnoea and impairing quality of life (QoL). Indwelling pleural catheters (IPCs) are a novel management approach allowing ambulatory fluid drainage and are increasingly used as an alternative to pleurodesis. IPC drainage approaches vary greatly between centres. Some advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages however demand considerably more resources and may increase risks of complications. Others believe that MPE care is palliative and drainage should be performed only when patients become symptomatic (often weekly to monthly). Identifying the best drainage approach will optimise patient care and healthcare resource utilisation. Methods and analysis A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings. Trial registration number ACTRN12615000963527; Pre-results.

Original languageEnglish (US)
Article numbere011480
JournalBMJ Open
Volume6
Issue number7
DOIs
StatePublished - Jul 1 2016

Fingerprint

Malignant Pleural Effusion
Indwelling Catheters
Pleurodesis
Multicenter Studies
Drainage
Visual Analog Scale
Dyspnea
Quality of Life
Research Ethics Committees
Lost to Follow-Up
Mesothelioma
Palliative Care
Ethics
Health Care Costs
Neoplasms
Patient Care
Exercise
Delivery of Health Care
Lung

Keywords

  • cancer
  • dyspnoea
  • indwelling pleural catheter
  • malignant
  • Pleural effusion
  • randomised trial

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Protocol of the Australasian Malignant Pleural Effusion-2 (AMPLE-2) trial : A multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters. / Azzopardi, Maree; Thomas, Rajesh; Muruganandan, Sanjeevan; Lam, David C L; Garske, Luke A.; Kwan, Benjamin C H; Rashid Ali, Muhammad Redzwan S; Nguyen, Phan T.; Yap, Elaine; Horwood, Fiona C.; Ritchie, Alexander J.; Bint, Michael; Tobin, Claire L.; Shrestha, Ranjan; Piccolo, Francesco; De Chaneet, Christian C.; Creaney, Jenette; Newton, Robert U.; Hendrie, Delia; Murray, Kevin; Read, Catherine A.; Feller-Kopman, David; Maskell, Nick A.; Gary Lee, Y. C.

In: BMJ Open, Vol. 6, No. 7, e011480, 01.07.2016.

Research output: Contribution to journalArticle

Azzopardi, M, Thomas, R, Muruganandan, S, Lam, DCL, Garske, LA, Kwan, BCH, Rashid Ali, MRS, Nguyen, PT, Yap, E, Horwood, FC, Ritchie, AJ, Bint, M, Tobin, CL, Shrestha, R, Piccolo, F, De Chaneet, CC, Creaney, J, Newton, RU, Hendrie, D, Murray, K, Read, CA, Feller-Kopman, D, Maskell, NA & Gary Lee, YC 2016, 'Protocol of the Australasian Malignant Pleural Effusion-2 (AMPLE-2) trial: A multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters', BMJ Open, vol. 6, no. 7, e011480. https://doi.org/10.1136/bmjopen-2016-011480
Azzopardi, Maree ; Thomas, Rajesh ; Muruganandan, Sanjeevan ; Lam, David C L ; Garske, Luke A. ; Kwan, Benjamin C H ; Rashid Ali, Muhammad Redzwan S ; Nguyen, Phan T. ; Yap, Elaine ; Horwood, Fiona C. ; Ritchie, Alexander J. ; Bint, Michael ; Tobin, Claire L. ; Shrestha, Ranjan ; Piccolo, Francesco ; De Chaneet, Christian C. ; Creaney, Jenette ; Newton, Robert U. ; Hendrie, Delia ; Murray, Kevin ; Read, Catherine A. ; Feller-Kopman, David ; Maskell, Nick A. ; Gary Lee, Y. C. / Protocol of the Australasian Malignant Pleural Effusion-2 (AMPLE-2) trial : A multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters. In: BMJ Open. 2016 ; Vol. 6, No. 7.
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abstract = "Introduction Malignant pleural effusions (MPEs) can complicate most cancers, causing dyspnoea and impairing quality of life (QoL). Indwelling pleural catheters (IPCs) are a novel management approach allowing ambulatory fluid drainage and are increasingly used as an alternative to pleurodesis. IPC drainage approaches vary greatly between centres. Some advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages however demand considerably more resources and may increase risks of complications. Others believe that MPE care is palliative and drainage should be performed only when patients become symptomatic (often weekly to monthly). Identifying the best drainage approach will optimise patient care and healthcare resource utilisation. Methods and analysis A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5{\%} significance, 90{\%} power) assuming a common between-group SD of 18.9 mm and a 10{\%} lost to follow-up rate. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings. Trial registration number ACTRN12615000963527; Pre-results.",
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T2 - A multicentre randomised study of aggressive versus symptom-guided drainage via indwelling pleural catheters

AU - Azzopardi, Maree

AU - Thomas, Rajesh

AU - Muruganandan, Sanjeevan

AU - Lam, David C L

AU - Garske, Luke A.

AU - Kwan, Benjamin C H

AU - Rashid Ali, Muhammad Redzwan S

AU - Nguyen, Phan T.

AU - Yap, Elaine

AU - Horwood, Fiona C.

AU - Ritchie, Alexander J.

AU - Bint, Michael

AU - Tobin, Claire L.

AU - Shrestha, Ranjan

AU - Piccolo, Francesco

AU - De Chaneet, Christian C.

AU - Creaney, Jenette

AU - Newton, Robert U.

AU - Hendrie, Delia

AU - Murray, Kevin

AU - Read, Catherine A.

AU - Feller-Kopman, David

AU - Maskell, Nick A.

AU - Gary Lee, Y. C.

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N2 - Introduction Malignant pleural effusions (MPEs) can complicate most cancers, causing dyspnoea and impairing quality of life (QoL). Indwelling pleural catheters (IPCs) are a novel management approach allowing ambulatory fluid drainage and are increasingly used as an alternative to pleurodesis. IPC drainage approaches vary greatly between centres. Some advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages however demand considerably more resources and may increase risks of complications. Others believe that MPE care is palliative and drainage should be performed only when patients become symptomatic (often weekly to monthly). Identifying the best drainage approach will optimise patient care and healthcare resource utilisation. Methods and analysis A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings. Trial registration number ACTRN12615000963527; Pre-results.

AB - Introduction Malignant pleural effusions (MPEs) can complicate most cancers, causing dyspnoea and impairing quality of life (QoL). Indwelling pleural catheters (IPCs) are a novel management approach allowing ambulatory fluid drainage and are increasingly used as an alternative to pleurodesis. IPC drainage approaches vary greatly between centres. Some advocate aggressive (usually daily) removal of fluid to provide best symptom control and chance of spontaneous pleurodesis. Daily drainages however demand considerably more resources and may increase risks of complications. Others believe that MPE care is palliative and drainage should be performed only when patients become symptomatic (often weekly to monthly). Identifying the best drainage approach will optimise patient care and healthcare resource utilisation. Methods and analysis A multicentre, open-label randomised trial. Patients with MPE will be randomised 1:1 to daily or symptom-guided drainage regimes after IPC insertion. Patient allocation to groups will be stratified for the cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group status 0-1 vs ≥2), presence of trapped lung (vs not) and prior pleurodesis (vs not). The primary outcome is the mean daily dyspnoea score, measured by a 100 mm visual analogue scale (VAS) over the first 60 days. Secondary outcomes include benefits on physical activity levels, rate of spontaneous pleurodesis, complications, hospital admission days, healthcare costs and QoL measures. Enrolment of 86 participants will detect a mean difference of VAS score of 14 mm between the treatment arms (5% significance, 90% power) assuming a common between-group SD of 18.9 mm and a 10% lost to follow-up rate. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study (number 2015-043). Results will be published in peer-reviewed journals and presented at scientific meetings. Trial registration number ACTRN12615000963527; Pre-results.

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KW - dyspnoea

KW - indwelling pleural catheter

KW - malignant

KW - Pleural effusion

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