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Pleural controversies: indwelling pleural catheter vs. pleurodesis for malignant pleural effusions.

ABSTRACT: Malignant pleural effusions (MPE) are frequent consequences of malignant disease and significantly impair the quality of life (QoL) of patients. There are two main options for the palliation of MPE-related symptoms: obliterating the pleural space by pleurodesis to prevent further fluid reaccumulation, or chronically draining the pleural fluid with an indwelling pleural catheter (IPC). There is controversy as to which approach is superior each having advantages and drawbacks. Pleurodesis offers a higher chance of rapid resolution of the pleural effusion with an intervention that is time limited but at the expense of a more invasive procedure, the need for a hospital stay and a higher need for repeat procedures. IPC offers an outpatient solution which is less invasive but at the cost of prolonged catheter drainages and care in a significant portion of patients who will not achieve pleurodesis. Impact on QoL, symptom relief and costs do not appear to be significantly different between the two options. Treatment of MPE should be tailored to the patient's functional status, comorbidities, prognosis and personal preferences as well as local expertise. Hybrid approaches using pleurodesis techniques and IPC concomitantly may come into play in the near future to further improve patient care.

SUBMITTER: Fortin M

PROVIDER: S-EPMC4466431 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Pleural controversies: indwelling pleural catheter vs. pleurodesis for malignant pleural effusions.

Fortin Marc M Tremblay Alain A

Journal of thoracic disease 20150601 6

Malignant pleural effusions (MPE) are frequent consequences of malignant disease and significantly impair the quality of life (QoL) of patients. There are two main options for the palliation of MPE-related symptoms: obliterating the pleural space by pleurodesis to prevent further fluid reaccumulation, or chronically draining the pleural fluid with an indwelling pleural catheter (IPC). There is controversy as to which approach is superior each having advantages and drawbacks. Pleurodesis offers a ...[more]

PMID: 26150918

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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: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: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:ImportanceMalignant pleural effusion (MPE) is challenging to manage. Talc pleurodesis is a common and effective treatment. There are no reliable data, however, regarding the optimal method for talc delivery, leading to differences in practice and recommendations.ObjectiveTo test the hypothesis that administration of talc poudrage during thoracoscopy with local anesthesia is more effective than talc slurry delivered via chest tube in successfully inducing pleurodesis.Design, setting, and participantsOpen-label, randomized clinical trial conducted at 17 UK hospitals. A total of 330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018. Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia. Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung.InterventionsPatients randomized to the talc poudrage group (n?=?166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation, while patients randomized to the control group (n?=?164) underwent bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry.Main outcomes and measuresThe primary outcome was pleurodesis failure up to 90 days after randomization. Secondary outcomes included pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life at 30, 90, and 180 days; all-cause mortality; and percentage of opacification on chest radiograph at drain removal and at 30, 90, and 180 days.ResultsAmong 330 patients who were randomized (mean age, 68 years; 181 [55%] women), 320 (97%) were included in the primary outcome analysis. At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P?=?.74; difference, -1.8% [95% CI, -10.7% to 7.2%]). No statistically significant differences were noted in any of the 24 prespecified secondary outcomes.Conclusions and relevanceAmong patients with malignant pleural effusion, thoracoscopic talc poudrage, compared with talc slurry delivered via chest tube, resulted in no significant difference in the rate of pleurodesis failure at 90 days. However, the study may have been underpowered to detect small but potentially important differences.Trial registrationISRCTN Identifier: ISRCTN47845793.

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

Pleural controversies: indwelling pleural catheter vs. pleurodesis for malignant pleural effusions.

Publications

Pleural controversies: indwelling pleural catheter vs. pleurodesis for malignant pleural effusions.

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