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Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis.

ABSTRACT: Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients' remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources.The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores.The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The trial results will be published in peer-reviewed journals and presented at scientific conferences.Australia New Zealand Clinical Trials Registry-ACTRN12611000567921; National Institutes of Health-NCT02045121.

SUBMITTER: Fysh ET

PROVIDER: S-EPMC4225240 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis.

Fysh Edward T H ET Thomas Rajesh R Read Catherine A CA Kwan Ben C H BC Yap Elaine E Horwood Fiona C FC Lee Pyng P Piccolo Francesco F Shrestha Ranjan R Garske Luke A LA Lam David C L DC Rosenstengel Andrew A Bint Michael M Murray Kevin K Smith Nicola A NA Lee Y C Gary YC

BMJ open 20141106 11

<h4>Introduction</h4>Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional managem ...[more]

PMID: 25377015

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Project description:IntroductionMalignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery.Methods and analysisA multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months and good performance status randomised 1:1 to either IPC or VATS pleurodesis. Participant randomisation will be minimised for (i) cancer type (mesothelioma vs non-mesothelioma); (ii) previous pleurodesis (vs not); and (iii) trapped lung, if known (vs not). Primary outcome is the need for further ipsilateral pleural interventions over 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months.Ethics and disseminationSir Charles Gairdner and Osborne Park Health Care Group (HREC) has approved the study (reference: RGS356). Results will be published in peer-reviewed journals and presented at scientific meetings.DiscussionBoth IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12618001013257 . Registered on 18 June 2018.Protocol versionVersion 3.00/4.02.19.

Project description:ImportanceIndwelling pleural catheter and talc pleurodesis are established treatments for malignant pleural effusions among patients with poor prognosis.ObjectiveTo determine whether indwelling pleural catheters are more effective than talc pleurodesis in reducing total hospitalization days in the remaining lifespan of patients with malignant pleural effusion.Design, setting, and participantsThis open-label, randomized clinical trial included participants recruited from 9 centers in Australia, New Zealand, Singapore, and Hong Kong between July 2012 and October 2014; they were followed up for 12 months (study end date: October 16, 2015). Patients (n?=?146) with symptomatic malignant pleural effusion who had not undergone indwelling pleural catheter or pleurodesis treatment were included.InterventionsParticipants were randomized (1:1) to indwelling pleural catheter (n?=?74) or talc pleurodesis (n?=?72), minimized by malignancy (mesothelioma vs others) and trapped lung (vs not), and stratified by region (Australia vs Asia).Main outcomes and measuresThe primary end point was the total number of days spent in hospital from procedure to death or to 12 months. Secondary outcomes included further pleural interventions, patient-reported breathlessness, quality-of-life measures, and adverse events.ResultsAmong the 146 patients who were randomized (median age, 70.5 years; 56.2% male), 2 withdrew before receiving the randomized intervention and were excluded. The indwelling pleural catheter group spent significantly fewer days in hospital than the pleurodesis group (median, 10.0 [interquartile range [IQR], 3-17] vs 12.0 [IQR, 7-21] days; P?=?.03; Hodges-Lehmann estimate of difference, 2.92 days; 95% CI, 0.43-5.84). The reduction was mainly in effusion-related hospitalization days (median, 1.0 [IQR, 1-3] day with the indwelling pleural catheter vs 4.0 (IQR, 3-6) days with pleurodesis; P?<?.001; Hodges-Lehmann estimate, 2.06 days; 95% CI, 1.53-2.58). Fewer patients randomized to indwelling pleural catheter required further ipsilateral invasive pleural drainages (4.1% vs 22.5%; difference, 18.4%; 95% CI, 7.7%-29.2%). There were no significant differences in improvements in breathlessness or quality of life offered by indwelling pleural catheter or talc pleurodesis. Adverse events were seen in 22 patients in the indwelling pleural catheter group (30 events) and 13 patients in the pleurodesis group (18 events).Conclusions and relevanceAmong patients with malignant pleural effusion, treatment with an indwelling pleural catheter vs talc pleurodesis resulted in fewer hospitalization days from treatment to death, but the magnitude of the difference is of uncertain clinical importance. These findings may help inform patient choice of management for pleural effusion.Trial registrationanzctr.org.au Identifier: ACTRN12611000567921.

Project description:BackgroundTunnelled pleural catheters used to treat malignant pleural effusions may achieve pleurodesis. We aimed to identify factors associated with higher pleurodesis rates and earlier catheter removal.MethodsWe retrospectively reviewed a prospective database of tunnelled pleural catheters inserted consecutively between May 2006 and June 2013 for confirmed malignant pleural effusion. The cohort included patients who underwent medical thoracoscopy. Clinical, radiologic and pleural fluid data were recorded. We used logistic regression and Cox regression to assess rates of and days to pleurodesis, respectively.ResultsWe analyzed data for 1071 tunnelled pleural catheters in 956 patients. Increased rates of pleurodesis were associated with lymphoma (odds ratio [OR] 3.49, 95% confidence interval [CI] 1.93-6.33), ovarian cancer (OR 2.93, 95% CI 1.68-5.11), Eastern Cooperative Oncology Group Scale of Performance Status grade 2 or less (OR 2.79, 95% CI 1.79-4.34), medical thoracoscopy (OR 2.21, 95% CI 1.28-3.85), protein level (OR 1.03, 95% CI 1.01-1.06), albumin level (OR 1.07, 95% CI 1.03-1.12) and percent eosinophils (OR 1.04, 95% CI 1.00-1.07). Reduced rates of pleurodesis were associated with gastrointestinal cancers (OR 0.41, 95% CI 0.19-0.87), hydropneumothorax on the postdrainage chest radiograph (OR 0.62, 95% CI 0.41-0.94) and percent other cells on cell count (OR 0.98, 95% CI 0.97-0.99). Earlier pleurodesis was associated with ovarian cancer (hazard ratio [HR] 1.48, 95% CI 1.06-2.08), medical thoracoscopy (HR 1.45, 95% CI 1.10-1.92), protein level (HR 1.03, 95% CI 1.01-1.04) and percent eosinophils (HR 1.02, 95% CI 1.00-1.04). Delayed pleurodesis was associated with breast cancer (HR 0.61, 95% CI 0.46-0.81), hydropneumothorax with 80% or less lung expansion (HR 0.55, 95% CI 0.38-0.80) and percent other cells (HR 0.99, 95% CI 0.98-1.00).InterpretationClinicians should consider numerous factors to predict the probability of and timing to pleurodesis with tunnelled pleural catheters.

Dataset Information

Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis.

Publications

Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis.

Similar Datasets

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