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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 M 1 , Thomas R 1 , Muruganandan S 2 , Lam DC 3 , Garske LA 4 , Kwan BC 5 Show all authors , Rashid Ali MR 6 , Nguyen PT 7 , Yap E 8 , Horwood FC 8 , Ritchie AJ 9 , Bint M 10 , Tobin CL 11 , Shrestha R 12 , Piccolo F 13 , De Chaneet CC 14 , Creaney J 15 , Newton RU 16 , Hendrie D 17 , Murray K 18 , Read CA 19 , Feller-Kopman D 20 , Maskell NA 21 , Lee YC 22

Affiliations 

  • 1 Department of Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia Pleural Medicine Unit, Institute for Respiratory Health, Perth, Western Australia, Australia
  • 2 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
  • 3 Department of Medicine, University of Hong Kong, Hong Kong, China
  • 4 Wesley Hospital, Brisbane, Queensland, Australia
  • 5 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
  • 6 Respiratory Department, Queen Elizabeth Hospital, Ministry of Health Malaysia, Kota Kinabalu, Sabah, Malaysia
  • 7 The Department of Thoracic Medicine, The Royal Adelaide Hospital, Adelaide, South Australia, Australia
  • 8 Respiratory Department, Middlemore Hospital, Auckland, New Zealand
  • 9 Department of Thoracic Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
  • 10 Department of Respiratory Medicine, Sunshine Coast Hospital and Health Service, Nambour, Queensland, Australia
  • 11 Respiratory Department, Royal Perth Hospital, Perth, Western Australia, Australia
  • 12 Department of Respiratory Medicine, Fiona Stanley Hospital, Perth, Western Australia, Australia
  • 13 Saint John of God Public and Private Hospital Midland, Midland, Western Australia, Australia
  • 14 Bunbury Hospital, Western Australian Country Health Service, Bunbury, Western Australia, Australia Saint John of God Hospital Bunbury, Bunbury, Western Australia, Australia
  • 15 National Centre for Asbestos Related Diseases, School of Medicine and Pharmacology, University of Western Australia, Perth, Western Australia, Australia
  • 16 Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia Institute of Human Performance, The University of Hong Kong, Hong Kong
  • 17 School of Public Health, Curtin University, Perth, Western Australia, Australia
  • 18 Centre for Applied Statistics, University of Western Australia, Perth, Western Australia, Australia
  • 19 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
  • 20 Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, USA
  • 21 Academic Respiratory Unit, School of Clinical Sciences, University of Bristol, Bristol, UK
  • 22 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
BMJ Open, 2016 07 05;6(7):e011480.
PMID: 27381209 DOI: 10.1136/bmjopen-2016-011480

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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