Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis.
BACKGROUND
Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients' remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources.


METHODS
The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores.


BACKGROUND
The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The trial results will be published in peer-reviewed journals and presented at scientific conferences.


BACKGROUND
Australia New Zealand Clinical Trials Registry-ACTRN12611000567921; National Institutes of Health-NCT02045121.
Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia Lung Institute of Western Australia, Perth, Western Australia, Australia.
Edward T H
ET
Fysh
Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia Lung Institute of Western Australia, Perth, Western Australia, Australia.
Rajesh
R
Thomas
Lung Institute of Western Australia, Perth, Western Australia, Australia.
Catherine A
CA
Read
Ben C H
BC
Kwan
Department of Respiratory and Sleep Medicine, The Sutherland Hospital, Sydney, New South Wales, Australia Department of Respiratory Medicine, St George Hospital, Sydney, Australia.
Ben C H
BC
Lam
Department of Respiratory Medicine, Middlemore Hospital, Auckland, New Zealand.
Elaine
E
Yap
Department of Respiratory Medicine, Middlemore Hospital, Auckland, New Zealand.
Fiona C
FC
Horwood
Division of Respiratory & Critical Care Medicine, Department of Medicine, Yong Loo Lin Medical School, National University Hospital, National University of Singapore, Singapore.
Pyng
P
Lee
Department of Internal Medicine, Swan District Hospital, Perth, Australia.
Francesco
F
Piccolo
Department of Respiratory Medicine, Fremantle Hospital, Fremantle, Australia.
Ranjan
R
Shrestha
Department of Respiratory and Sleep Medicine, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
Luke A
LA
Garske
Department of Medicine, University of Hong Kong, Kong SAR, China.
David C L
DC
Lam
School of Medicine, University of Queensland, Brisbane, Queensland, Australia Holy Spirit Northside Hospital, Brisbane, Queensland, Australia.
Andrew
A
Rosenstengel
Department of Respiratory Medicine, Nambour General Hospital, Sunshine Coast, Queensland, Australia.
Michael
M
Bint
Centre for Applied Statistics, University of Western Australia, Perth, Western Australia, Australia.
Kevin
K
Murray
Medical Research Institute of New Zealand, Wellington Hospital, Wellington, New Zealand.
Nicola A
NA
Smith
Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia Lung Institute of Western Australia, Perth, Western Australia, Australia.
Y C Gary
YC
Lee
D002408:Catheters, Indwelling; D002985:Clinical Protocols; D006801:Humans; D016066:Pleural Effusion, Malignant / Q000628:therapy*; D018700:Pleurodesis; D011446:Prospective Studies; D013627:Talc / Q000008:administration & dosage*
D013627:Talc