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

Our plain-English summary of 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, by M. Azzopardi, R. Thomas, S. Muruganandan, et al (BMJ Open, 2016).

The study

• Authors: M. Azzopardi, R. Thomas, S. Muruganandan, D.C. Lam, L.A. Garske, B.C. Kwan, M.R. Rashid Ali, P.T. Nguyen, E. Yap, F.C. Horwood, A.J. Ritchie, M. Bint, C.L. Tobin, R. Shrestha, F. Piccolo, C.C. De Chaneet, J. Creaney, R.U. Newton, D. Hendrie, K. Murray, C.A. Read, D. Feller-Kopman, N.A. Maskell, Y.C. Lee
• Journal: BMJ Open
• Published: 2016;6(7):e011480
• Type of article: Randomized trial
• Cited by: 15 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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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In plain English

This protocol describes a planned trial, AMPLE-2, and reports no results. The trial was designed for adults with malignant pleural effusion (fluid around the lung caused by cancer) who needed an indwelling pleural catheter, a tube left in place for draining fluid. Centres in Australia, New Zealand, Hong Kong and Malaysia were to randomly assign 86 participants, in equal numbers, to one of two drainage plans. One group would drain every day for the first 60 days unless this was clinically contraindicated or the pleural surfaces fused on their own (spontaneous pleurodesis). The other would drain only when symptoms such as breathlessness returned, or at least once per fortnight. The attending physician could change drainage frequency if clinically indicated. Randomisation was to be balanced for cancer type (mesothelioma or other), performance status, trapped lung and prior pleurodesis. The main planned measure was daily breathlessness on a 100 mm scale over the first 60 days. Other planned measures included physical activity, spontaneous pleurodesis, complications, hospital days, costs and quality of life. The authors noted that patients and investigators could not be blinded to group.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Protocol for a multicentre, open-label randomised trial (no results reported)
• Who was studied: Planned: 86 adults with symptomatic malignant pleural effusion needing an indwelling pleural catheter, at centres in Australia, New Zealand, Hong Kong and Malaysia; randomisation balanced for mesothelioma vs non-mesothelioma and other factors
• Exposure: Not an asbestos exposure study. The intervention compared was daily (aggressive) drainage via the catheter for the first 60 days, unless clinically contraindicated or spontaneous pleurodesis occurred, versus drainage only when symptoms recur or at least once per fortnight (symptom-guided). The attending physician could modify drainage frequency if clinically indicated.
• Limitations the authors state:
  • Investigators and patients could not be blinded to the drainage group assigned

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma, Talc and vermiculite.

Medical terms in this study, explained in our Lexicon: Pleural Effusion, Indwelling Pleural Catheter, Quality of Life, Pleurodesis, Palliative Care, Mesothelioma, Performance Status, Trapped Lung.

Related studies

• Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial — S. Muruganandan, M. Azzopardi, et al. (2018)
• Indwelling pleural catheter versus talc pleurodesis for malignant pleural effusion: a meta-analysis — M. Yeung, E.W. Loh, et al. (2020)
• Interventional therapies for malignant pleural effusions: the present and the future — R. Thomas, R. Francis, et al. (2014)
• MesoTRAP: a feasibility study that includes a pilot clinical trial comparing video-assisted thoracoscopic partial pleurectomy decortication with indwelling pleural catheter in patients with trapped lung due to malignant pleural mesothelioma designed to address recruitment and randomisation uncertainties and sample size requirements for a phase III trial — C. Matthews, C. Freeman, et al. (2019)
• A multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma (RESPECT-MESO): study protocol for a randomised controlled trial — S. Gunatilake, F.J. Brims, et al. (2014)
• Intrapleural Fibrinolysis for the Treatment of Indwelling Pleural Catheter-Related Symptomatic Loculations: A Multicenter Observational Study — R. Thomas, F. Piccolo, et al. (2015)

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