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Pre-EDIT: protocol for a randomised feasibility trial of elastance-directed intrapleural catheter or talc pleurodesis (EDIT) in malignant pleural effusion.

ABSTRACT: Non-expansile lung (NEL) is a common cause of talc pleurodesis (TP) failure in malignant pleural effusion (MPE), but is often occult prior to drainage. Reliable detection of NEL would allow patients to be allocated between intrapleural catheter (IPC) and TP. High pleural elastance (PEL) has been associated with NEL in observational studies. Pre-EDIT is a randomised feasibility trial of elastance-directed IPC or TP (EDIT) management using a novel, purpose-built digital pleural manometer (Rocket Medical, UK).Consecutive patients with MPE without prior evidence of NEL or preference for IPC will be randomised 1:1 between EDIT management and standard care (an attempt at TP). The primary objective is to determine whether sufficient numbers of patients (defined as 30 within 12 months (or 15 over 6?months)) can be recruited and randomised to justify a subsequent phase III trial testing the efficacy of EDIT management. Secondary objectives include safety, technical feasibility and validation of study design elements, including the definition of PEL using 4D pleural MRI before and after fluid aspiration. EDIT involves PEL assessment during a large volume pleural fluid aspiration, followed by an attempt at TP or placement of an IPC within 24?hours. Patients will be allocated to IPC if the rolling average PEL sustained over at least 250?mL fluid aspirated (PEL250) is ? 14.5?cm H2O/L.Pre-EDIT was approved by the West of Scotland Regional Ethics Committee on 8 March 2017 (Ref: 17/WS/0042). Results will be presented at scientific meetings and published in peer-reviewed journals.NCT03319186; Pre-results.

SUBMITTER: Martin GA

PROVIDER: S-EPMC5976095 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Pre-EDIT: protocol for a randomised feasibility trial of elastance-directed intrapleural catheter or talc pleurodesis (EDIT) in malignant pleural effusion.

Martin Geoffrey A GA Tsim Selina S Kidd Andrew C AC Foster John E JE McLoone Philip P Chalmers Anthony A Blyth Kevin G KG

BMJ open respiratory research 20180529 1

<h4>Introduction</h4>Non-expansile lung (NEL) is a common cause of talc pleurodesis (TP) failure in malignant pleural effusion (MPE), but is often occult prior to drainage. Reliable detection of NEL would allow patients to be allocated between intrapleural catheter (IPC) and TP. High pleural elastance (P<sub>EL</sub>) has been associated with NEL in observational studies. Pre-EDIT is a randomised feasibility trial of elastance-directed IPC or TP (EDIT) management using a novel, purpose-built dig ...[more]

PMID: 29862030

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Project description: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.

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: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:Objective:To evaluate the role of intrapleural positioning of a pleural catheter in early lung expansion and pleurodesis success in patients with recurrent malignant pleural effusion (RMPE).Methods:This was a retrospective study nested into a larger prospective cohort study including patients with RMPE recruited from a tertiary university teaching hospital between June of 2009 and September of 2014. The patients underwent pleural catheter insertion followed by bedside pleurodesis. Chest CT scans were performed twice: immediately before pleurodesis (iCT) and 30 days after pleurodesis (CT30). Catheter positioning was categorized based on iCT scans as posterolateral, anterior, fissural, and subpulmonary. We used the pleural volume on iCT scans to estimate early lung expansion and the difference between the pleural volumes on CT30 and iCT scans to evaluate radiological success of pleurodesis. Clinical pleurodesis success was defined as no need for any other pleural procedure.Results:Of the 131 eligible patients from the original study, 85 were included in this nested study (64 women; mean age: 60.74 years). Catheter tip positioning was subpulmonary in 35 patients (41%), anterior in 23 (27%), posterolateral in 17 (20%), and fissural in 10 (12%). No significant differences were found among the groups regarding early lung expansion (median residual pleural cavity = 377 mL; interquartile range: 171-722 mL; p = 0.645), radiological success of pleurodesis (median volume = 33 mL; interquartile range: -225 to 257 mL; p = 0.923), and clinical success of pleurodesis (85.8%; p = 0.676).Conclusions:Our results suggest that the position of the tip of the pleural catheter influences neither early lung expansion nor bedside pleurodesis success in patients with RMPE.Objetivo:Avaliar o papel do posicionamento intrapleural do cateter pleural na expansão pulmonar precoce e no sucesso da pleurodese em pacientes com derrame pleural maligno recorrente (DPMR).Métodos:Trata-se de um estudo retrospectivo aninhado em um estudo prospectivo de coorte maior com pacientes com DPMR recrutados em um hospital-escola universitário terciário entre junho de 2009 e setembro de 2014. Os pacientes foram submetidos a inserção de cateter pleural e, em seguida, pleurodese à beira do leito. A TC de tórax foi realizada duas vezes: imediatamente antes da pleurodese (TCi) e 30 dias após a pleurodese (TC30). Com base na TCi, a posição do cateter foi classificada em posterolateral, anterior, fissural e subpulmonar. Usamos o volume pleural na TCi para estimar a expansão pulmonar precoce e a diferença entre os volumes pleurais na TC30 e na TCi a fim de avaliar o sucesso radiológico da pleurodese. Considerou-se que a pleurodese teve êxito clínico quando não foi necessário realizar nenhum outro procedimento pleural.Resultados:Dos 131 pacientes elegíveis do estudo original, 85 foram incluídos neste estudo aninhado (64 mulheres; média de idade: 60,74 anos). A posição da ponta do cateter foi subpulmonar em 35 pacientes (41%), anterior em 23 (27%), posterolateral em 17 (20%) e fissural em 10 (12%). Não houve diferenças significativas entre os grupos quanto à expansão pulmonar precoce (mediana da cavidade pleural residual = 377 ml; intervalo interquartil: 171-722 ml; p = 0,645), sucesso radiológico da pleurodese (mediana do volume = 33 ml; intervalo interquartil: -225 a 257 ml; p = 0,923) e sucesso clínico da pleurodese (85,8%; p = 0,676).Conclusões:Nossos resultados sugerem que a posição da ponta do cateter pleural não influencia nem a expansão pulmonar precoce nem o sucesso da pleurodese à beira do leito em pacientes com DPMR.

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

Pre-EDIT: protocol for a randomised feasibility trial of elastance-directed intrapleural catheter or talc pleurodesis (EDIT) in malignant pleural effusion.

Publications

Pre-EDIT: protocol for a randomised feasibility trial of elastance-directed intrapleural catheter or talc pleurodesis (EDIT) in malignant pleural effusion.

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