The Australasian Malignant Pleural Effusion (AMPLE) Trial - 2 / ACTRN12615000963527 (updated Sept 2018)
Malignant pleural effusions (MPE) can complicate most cancers, causing dyspnea and impairment in quality of life (QoL). Indwelling pleural catheters (IPC) are a novel management approach allowing ambulatory fluid drainage, fewer invasive procedures and reduced hospitalizations than conventional talc pleurodesis.
IPC drainage approaches, however, vary greatly between centres and have a direct impact on patient care and major implications on healthcare resources. Some centres advocate aggressive (usually daily) removal of fluid to provide best symptom control and the chance of spontaneous pleurodesis. Daily drainages demand considerably more time, manpower and costs and may increase risks of complications. Other centres believe that MPE care should be symptom-based and drainage performed accordingly (often weekly to monthly).
The Australian Malignant PLeural Effusion (AMPLE) trial-2 is a multi-centre, open-labeled, randomized trial. Patients (n=86) with MPEs will be randomized 1:1 to either aggressive (daily) or symptom-guided drainage regimes after IPC insertion, with the aim to determine which regime is superior in improving clinical outcomes. The primary outcome is the mean daily dyspnea score, measured by a 100mm visual analogue scale (VAS), over the first 60 days. Secondary outcomes include benefits on activity levels, complications, hospital days, health costs, and QoL measures. This study is now closed following completion and is in the process of being reviewed for publication.
The study builds on AMPLE-1 study (146 MPE patients recruited over 27 months) and involves centres in Australia, New Zealand, Malaysia and Hong Kong. This study is powered (5% significance, 90% power) to detect a mean difference of VAS score of 14mm between groups and allows a 10% drop-out rate. This study addresses an urgent and practical question pertinent to the care of MPE; the results will add useful information to guide clinical practice. AMPLE-1 was published in JAMA in 2017.
Feasibility and efficacy of exercise in the management of malignant pleural mesothelioma - a collaborative study with Dr Carolyn McIntyre of Edith Cowan University Health and Wellness Institute.
Publicity articles (2016):
Primary Spontaneous Pneumothorax Trial / ACTRN12611000184976 (updated Sept 2018)
The Pleural Medicine Unit (PMU) is supporting this multicentre Australasian trial coordinated by the Centre for Clinical Research in Emergency Medicine (CCREM) at Royal Perth Hospital. At SCGH the PMU will be involved with the follow-up of participants following their recruitment and randomisation in the Emergency Department.
Primary spontaneous pneumothorax (PSP) is a significant global health problem affecting adolescents and young adults. Current management is variable, with sparse evidence from randomised controlled trials to guide treatment. Current guidelines emphasize the importance of intervention in most patients, which involves insertion of a chest drain, hospital admission, and thoracic surgery in some. This approach has recently been questioned and there is evidence to suggest that conservative management without intervention is effective and safe. The risk of recurrence may also be lower with conservative treatment because of better healing of the lung defect during slow re-expansion of the lung.
The trial proposes to address the fundamental management question of conservative versus invasive management in a multicentre randomised controlled trial that will be the largest study of PSP ever undertaken. It has the potential to reduce morbidity and deliver economic benefits through reductions in procedures, complications and hospital admissions.
The study paper will be written up to include one year follow up. The data is being analysed and it is hoped that the paper will be published in 2018.
STOPPE study: Steroid Therapy and Outcome of Parapneumonic Pleural Effusions – a randomized clinical trial / ACTRN12618000947202
STOPPE is a pilot, multicentre, double-blinded, placebo-controlled randomised controlled trial to be conducted by the Western Australia pleural teams at Sir Charles Gairdner (lead site), Fiona Stanley, Royal Perth and SJoG Midland Hospitals. Eighty patients admitted with CAP who have an effusion will be randomized 2:1 to receive intravenous dexamethasone (4mg bd for 48 hours) or placebo. Exclusion criteria will include immunosuppression, long-term steroid use and poorly-controlled diabetes. Randomisation will be minimized for likelihood of a complicated effusion (Chalmers score), size of the effusion on chest x-ray and diabetes. Outcomes will include time to clinical stability, change in markers of inflammation, proportion requiring a pleural procedure, change in pleural effusion volume and adverse events.
The study will establish the feasibility and safety of adjunct corticosteroid therapy in patients with pneumonia and associated pleural effusions. Participants will be randomized at trial entry, on a 2:1 basis, to either IV dexamethasone 4mg bd for 48 hours or placebo. They will be further managed according to best clinical practice with decisions about care made by the treating physician.
AMPLE-3: A Randomised Study Comparing Combined Indwelling Pleural Catheter (IPC) and Talc Pleurodesis with Video-Assisted Thoracoscopic Surgery (VATS )for the Management of Patients with Malignant Pleural Effusion / ACTRN12618001303257
The Australian Malignant PLeural Effusion (AMPLE) trial-3 is a multi-centre, open-labelled, randomised controlled (trial entry) study. One hundred and sixty patients with malignant pleural effusions (MPE), who are suitable for surgical pleurodesis and have a predicted survival of greater than 6 months, will be randomised 1:1 to either video assisted thoroscoscopic surgery (VATs) or indwelling pleural catheter (IPC) insertion with talc pleurodesis, if appropriate. MPE is defined as either histocytologically proven pleural malignancy or an exudative effusion with no other cause in a patient with known primary extra-pleural malignancy. Minimisation for i) cancer type (mesothelioma vs non-mesothelioma); ii) previous pleurodesis (vs not); iii) trapped lung, if known (vs not) will be performed. The nature of the intervention means that investigators and patients cannot be blinded to the treatment arms.
Primary endpoint: The primary outcome is the percentage of patients in each group requiring a repeat invasive pleural intervention for symptomatic recurrence of the effusion within 12 months or until death, if sooner. Pleural intervention is defined as an ipsilateral surgical procedure, chest drain insertion or thoracentesis with therapeutic intent. Clinically indicated diagnostic sampling procedures (e.g. to exclude infection) are excluded.