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

TitleProtocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis
Authors
Issue Date2014
PublisherBMJ Publishing Group: BMJ Open. The Journal's web site is located at http://bmjopen.bmj.com
Citation
BMJ Open, 2014, v. 4, p. article no. e006757 How to Cite?
AbstractINTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBERS: Australia New Zealand Clinical Trials Registry-ACTRN12611000567921; National Institutes of Health-NCT02045121.
Persistent Identifierhttp://hdl.handle.net/10722/207901
ISSN
2015 Impact Factor: 2.562
2015 SCImago Journal Rankings: 1.448
PubMed Central ID
Errata

 

DC FieldValueLanguage
dc.contributor.authorFysh, ETH-
dc.contributor.authorThomas, R-
dc.contributor.authorRead, CA-
dc.contributor.authorLam, BCH-
dc.contributor.authorYap, E-
dc.contributor.authorHorwood, FC-
dc.contributor.authorLee, P-
dc.contributor.authorPiccolo, F-
dc.contributor.authorShrestha, R-
dc.contributor.authorGarske, LA-
dc.contributor.authorLam, CLD-
dc.contributor.authorRosenstengel, A-
dc.contributor.authorBint, M-
dc.contributor.authorMurray, K-
dc.contributor.authorSmith, NA-
dc.contributor.authorLee, YCG-
dc.date.accessioned2015-01-26T01:47:09Z-
dc.date.available2015-01-26T01:47:09Z-
dc.date.issued2014-
dc.identifier.citationBMJ Open, 2014, v. 4, p. article no. e006757-
dc.identifier.issn2044-6055-
dc.identifier.urihttp://hdl.handle.net/10722/207901-
dc.description.abstractINTRODUCTION: 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBERS: Australia New Zealand Clinical Trials Registry-ACTRN12611000567921; National Institutes of Health-NCT02045121.-
dc.languageeng-
dc.publisherBMJ Publishing Group: BMJ Open. The Journal's web site is located at http://bmjopen.bmj.com-
dc.relation.ispartofBMJ Open-
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.titleProtocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesisen_US
dc.typeArticleen_US
dc.identifier.emailLam, CLD: dcllam@hku.hk-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1136/bmjopen-2014-006757-
dc.identifier.pmid25377015-
dc.identifier.pmcidPMC4225240-
dc.identifier.scopuseid_2-s2.0-84912035931-
dc.identifier.hkuros254520-
dc.identifier.volume4-
dc.identifier.spagearticle no. e006757-
dc.identifier.epagearticle no. e006757-
dc.publisher.placeUnited Kingdom-
dc.relation.erratumdoi:10.1136/bmjopen-2014-006757corr1-

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