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.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ACTRN12615000963527; Pre-results.
authors.affiliation: Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Pleural Medicine Unit, Institute for Respiratory Health, Perth, Western Australia, Australia.
authors.forename: Maree
authors.initials: M
authors.lastname: Azzopardi
authors.affiliation: Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Pleural Medicine Unit, Institute for Respiratory Health, Perth, Western Australia, Australia.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Thomas
authors.affiliation: Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Centre for Respiratory Health, School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Sanjeevan
authors.initials: S
authors.lastname: Muruganandan
authors.affiliation: Department of Medicine, University of Hong Kong, Hong Kong, China.
authors.forename: David C L
authors.initials: DC
authors.lastname: Lam
authors.affiliation: Wesley Hospital, Brisbane, Queensland, Australia.
authors.forename: Luke A
authors.initials: LA
authors.lastname: Garske
authors.affiliation: St George and Sutherland Hospital Clinical School, University of New South Wales, Sydney, New South Wales, Australia Department of Respiratory and Sleep Medicine, Sutherland Hospital, Sydney, New South Wales, Australia.
authors.forename: Benjamin C H
authors.initials: BC
authors.lastname: Kwan
authors.affiliation: Respiratory Department, Queen Elizabeth Hospital, Ministry of Health Malaysia, Kota Kinabalu, Sabah, Malaysia.
authors.forename: Muhammad Redzwan S
authors.initials: MR
authors.lastname: Rashid Ali
authors.affiliation: The Department of Thoracic Medicine, The Royal Adelaide Hospital, Adelaide, South Australia, Australia.
authors.forename: Phan T
authors.initials: PT
authors.lastname: Nguyen
authors.affiliation: Respiratory Department, Middlemore Hospital, Auckland, New Zealand.
authors.forename: Elaine
authors.initials: E
authors.lastname: Yap
authors.affiliation: Respiratory Department, Middlemore Hospital, Auckland, New Zealand.
authors.forename: Fiona C
authors.initials: FC
authors.lastname: Horwood
authors.affiliation: Department of Thoracic Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.
authors.forename: Alexander J
authors.initials: AJ
authors.lastname: Ritchie
authors.affiliation: Department of Respiratory Medicine, Sunshine Coast Hospital and Health Service, Nambour, Queensland, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Bint
authors.affiliation: Respiratory Department, Royal Perth Hospital, Perth, Western Australia, Australia.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Tobin
authors.affiliation: Department of Respiratory Medicine, Fiona Stanley Hospital, Perth, Western Australia, Australia.
authors.forename: Ranjan
authors.initials: R
authors.lastname: Shrestha
authors.affiliation: Saint John of God Public and Private Hospital Midland, Midland, Western Australia, Australia.
authors.forename: Francesco
authors.initials: F
authors.lastname: Piccolo
authors.affiliation: Bunbury Hospital, Western Australian Country Health Service, Bunbury, Western Australia, Australia Saint John of God Hospital Bunbury, Bunbury, Western Australia, Australia.
authors.forename: Christian C
authors.initials: CC
authors.lastname: De Chaneet
authors.affiliation: National Centre for Asbestos Related Diseases, School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Jenette
authors.initials: J
authors.lastname: Creaney
authors.affiliation: Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia Institute of Human Performance, The University of Hong Kong, Hong Kong.
authors.forename: Robert U
authors.initials: RU
authors.lastname: Newton
authors.affiliation: School of Public Health, Curtin University, Perth, Western Australia, Australia.
authors.forename: Delia
authors.initials: D
authors.lastname: Hendrie
authors.affiliation: Centre for Applied Statistics, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Kevin
authors.initials: K
authors.lastname: Murray
authors.affiliation: Pleural Medicine Unit, Institute for Respiratory Health, Perth, Western Australia, Australia Centre for Respiratory Health, School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Read
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: David
authors.initials: D
authors.lastname: Feller-Kopman
authors.affiliation: Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: Nick A
authors.initials: NA
authors.lastname: Maskell
authors.affiliation: Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Pleural Medicine Unit, Institute for Respiratory Health, Perth, Western Australia, Australia Centre for Respiratory Health, School of Medicine & Pharmacology, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Y C Gary
authors.initials: YC
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia / Q000453:epidemiology; D001826:Body Fluids; D002408:Catheters, Indwelling; D002985:Clinical Protocols; D004322:Drainage / Q000379:methods; D004417:Dyspnea / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006723:Hong Kong / Q000453:epidemiology; D006801:Humans; D008175:Lung Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D008654:Mesothelioma / Q000453:epidemiology / Q000517:prevention & control*; D000086002:Mesothelioma, Malignant; D009520:New Zealand / Q000453:epidemiology; D016066:Pleural Effusion, Malignant / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D018700:Pleurodesis / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D013627:Talc; D016896:Treatment Outcome
chemical_list: D013627:Talc
keywords: Pleural effusion; cancer; dyspnoea; indwelling pleural catheter; malignant; randomised trial