Cargando…

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

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 d...

Descripción completa

Detalles Bibliográficos
Autores principales: 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, Lee, Y C Gary
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947772/
https://www.ncbi.nlm.nih.gov/pubmed/27381209
http://dx.doi.org/10.1136/bmjopen-2016-011480
_version_ 1782443227385692160
author 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
Lee, Y C Gary
author_facet 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
Lee, Y C Gary
author_sort Azzopardi, Maree
collection PubMed
description 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.
format Online
Article
Text
id pubmed-4947772
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-49477722016-08-03 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 Lee, Y C Gary BMJ Open Respiratory Medicine 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. BMJ Publishing Group 2016-07-05 /pmc/articles/PMC4947772/ /pubmed/27381209 http://dx.doi.org/10.1136/bmjopen-2016-011480 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Respiratory Medicine
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
Lee, Y C Gary
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Respiratory Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947772/
https://www.ncbi.nlm.nih.gov/pubmed/27381209
http://dx.doi.org/10.1136/bmjopen-2016-011480
work_keys_str_mv AT azzopardimaree protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT thomasrajesh protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT muruganandansanjeevan protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT lamdavidcl protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT garskelukea protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT kwanbenjaminch protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT rashidalimuhammadredzwans protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT nguyenphant protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT yapelaine protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT horwoodfionac protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT ritchiealexanderj protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT bintmichael protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT tobinclairel protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT shrestharanjan protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT piccolofrancesco protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT dechaneetchristianc protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT creaneyjenette protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT newtonrobertu protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT hendriedelia protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT murraykevin protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT readcatherinea protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT fellerkopmandavid protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT maskellnicka protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters
AT leeycgary protocoloftheaustralasianmalignantpleuraleffusion2ample2trialamulticentrerandomisedstudyofaggressiveversussymptomguideddrainageviaindwellingpleuralcatheters