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.
Abnormality of the pleura is a common clinical problem. It is usually seen in the setting of cancer that may arise from within the pleura (such as mesothelioma) or spread to the pleura from other sites, most commonly from the lung or breast. More than 8000 Australians suffer from a malignant pleural effusion secondary to cancer of the pleura every year causing disabling breathlessness.
Computed tomography (CT) is the standard imaging modality for detection of pleural abnormalities such as nodules or pleural thickening in the setting of a malignant pleural effusion (MPE), and usually guides diagnostic investigations, such as pleural biopsy. CT however, is often unable to detect small pleural nodules (~1cm) even when these nodules are visible on direct inspection, e.g. during thoracoscopy. As a consequence, many patients with suspected malignant pleural disease are forced to undergo surgery such as thoracoscopy to obtain histology for a diagnosis. Surgery has its attendant morbidity and many patients are not suitable to undergo surgical procedures due to age or underlying comorbidities leading to delayed diagnosis and treatment.
Objectives: We hypothesize that a CT scan is unable to easily detect pleural nodules because the pleural abnormality and surrounding lung and/or pleural effusion have similar CT density. We hypothesize that artificially creating an air-pleura interface will reveal small pleural nodules (~1cm) and allow significantly better detection of previously undetectable pleural abnormalities nodules by CT scan.