Project description:PURPOSE:Many patients diagnosed with advanced cancer have malignant pleural effusion that does not respond to chemotherapy or radiation therapy. These patients often have respiratory symptoms, especially dyspnea. In order to relieve these symptoms, various procedures including chemical pleurodesis have been performed. Although talc is the most widely used and effective sclerosing agent, there it has various adverse effects. The objective of this study was to determine whether Viscum (ABNOVA Viscum® Fraxini Injection, manufactured by ABNOVA GmbH, Germany) could be used as an agent to replace talc in clinical practice. METHODS:Data of 56 patients with malignant pleural effusion who received chemical pleurodesis after tube thoracostomy from January 2003 to December 2017 were retrospectively reviewed to analyze clinical course and response after pleurodesis with each agent. RESULTS:After pleurodesis, changes in numeric rating scale (NRS) was 1.4?±?1.6 in the talc group and 0.5?±?1.5 in the Viscum group (p?=?0.108). Changes in white blood cell counts after pleurodesis were 4154.8?±?6710.7 in the talc group and 3487.3?±?6067.7 in the Viscum group (p?=?0.702). Changes in C-reactive protein (CRP) were 9.03?±?6.86 in the talc group and 6.3?±?7.5 in the Viscum group (p?=?0.366). The success rate of pleurodesis was 93.3% in the talc group and 96% in the Viscum group (p?=?0.225). CONCLUSION:Viscum pleurodesis showed comparable treatment results with talc pleurodesis while its adverse effects such as chest pain and fever tended to be relatively weak.
Project description:BackgroundTalc pleurodesis has been widely used to control malignant pleural effusion; however, it is still not clear whether talc pleurodesis is more effective than other local therapies. We performed a meta-analysis to evaluate the efficacy and safety of talc pleurodesis in the management of malignant pleural effusion.MethodsPubMed, Embase, and Web of Science were searched for English-language studies of clinical controlled trials comparing talc pleurodesis with control therapies until August 8, 2013. Success rate and incidence of adverse events were evaluated. Relative risks were estimated using random- or fixed- effects model and statistical heterogeneity was assessed using I² test.ResultsTwenty trials involving 1,525 patients with malignant pleural effusion were included. The success rate of talc pleurodesis was significantly higher than that of control therapies (relative risk, 1.21; 95% confidence interval, 1.01-1.45; p = 0.035) with similar adverse events. In addition, thoracoscopic talc poudrage was more effective than bedside talc slurry (relative risk, 1.12; 95% confidence interval, 1.01-1.23; p = 0.026).ConclusionsThe current evidences suggested the benefit for talc pleurodesis in the treatment of malignant pleural effusion. Talc pleurodesis, especially thoracoscopic talc poudrage pleurodesis, should be performed in patients with malignant pleural effusion, especially those with life-expectancy longer than one month.
Project description:IntroductionThe management of recurrent malignant pleural effusions (MPE) can be challenging. Various options are available, with the most efficacious and widely used being talc pleurodesis. Talc can either be applied via a chest drain in the form of slurry, or at medical thoracoscopy using poudrage. Current evidence regarding which method is most effective is conflicting and often methodologically flawed. The TAPPS trial is a suitably powered, multicentre, open-label, randomised controlled trial designed to compare the pleurodesis success rate of medical thoracoscopy and talc poudrage with chest drain insertion and talc slurry.Methods and analysis330 patients with a confirmed MPE requiring intervention will be recruited from UK hospitals. Patients will be randomised (1:1) to undergo either small bore (<14 Fr) Seldinger chest drain insertion followed by instillation of sterile talc (4 g), or to undergo medical thoracoscopy and simultaneous poudrage (4 g). The allocated procedure will be performed as an inpatient within 3 days of randomisation taking place. Following discharge, patients will be followed up at regular intervals for 6 months. The primary outcome measure is pleurodesis failure rates at 3 months. Pleurodesis failure is defined as the need for further pleural intervention for fluid management on the side of the trial intervention.Ethics and disseminationThe trial has received ethical approval from the National Research Ethics Service Committee North West-Preston (12/NW/0467). There is a trial steering committee which includes independent members and a patient and public representative. The trial results will be published in a peer-reviewed journal and presented at international conferences, as well as being disseminated via local and national charities and patient groups. All participants who wish to know the study results will also be contacted directly on their publication.Trial registration numberISRCTN47845793.
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:BackgroundAutologous blood is a novel, high-efficacy sclerosant for treatment of malignant pleural effusion (MPE), similar to tetracycline. There has been no comparative data between autologous blood and a worldwide sclerosant like talc. We aimed to compare the effectiveness of autologous blood versus talc pleurodesis.MethodsA prospective study was conducted at Songklanagarind Hospital, Songkhla, Thailand. A total of 123 symptomatic MPE cases were randomized to receive autologous blood pleurodesis (ABP) versus pleurodesis with talc slurry. In the ABP group, 100 ml of autologous venous blood was instilled through a chest drain, followed by 50 ml of sterile normal saline (NSS). In the talc group, 20 ml of 1% lidocaine diluted in 30 ml NSS was instilled, followed by 4 g of sterile talc (Steritalc®, a non-small particle size talc) suspended in 100 ml of NSS. A 30-day pleurodesis efficacy (according to Paladine's criteria), along with the adverse events, was evaluated.ResultsFifty-six cases in the ABP, and 54 cases in the talc group completed the study. There was no difference between the two groups in the demographic data. The overall pleurodesis success rate at 30 days was 82.0% in the ABP group, comparable to the talc pleurodesis group (87.0%, p = 0.12). The percentage of fever (9.0% versus 28.0%, p = 0.04), amount of acetaminophen required by each participant (2.2 ± 0.7 versus 4.6 ± 0.9 tablets, p = 0.03), pain score and percentage of cases who needed opioids (9.0% versus 26.0%, p = 0.02) and hospital stay (10.2 ± 2.7 versus 12.8 ± 3.4, p = 0.04) were significantly lower in the ABP group; no infectious or serious events occurred.ConclusionsABP had an equivalent efficacy compared to talc pleurodesis for MPE treatment. ABP offered less fever and pain and could shorten hospital stays, and neither produced means ABP did not produce clotted drainage, pulmonary or systemic adverse events.
Project description:BackgroundTalc pleurodesis (TP) and indwelling pleural catheter (IPC) are used for the management of malignant pleural effusion (MPE). Our meta-analysis was conducted to assess the efficacy and safety of both treatments among patients with MPE.MethodsWe acquired pertinent randomized controlled trials (RCTs) by searching PubMed, ScienceDirect, the Cochrane Library, Scopus, Ovid Medline, Embase, Web of Science, and Google Scholar. The endpoints included survival, pleurodesis rates, total drainage, further pleural interventions, hospital days, symptoms, quality of life (QoL), and complications.ResultsWe included four high-quality RCTs. Both treatments were effective among patients with MPE and no previous pleurodesis, with comparable survival and equivalent relief of breathlessness. Additionally, the TP group had higher pleurodesis rates, less total drainage, and fewer all-grade complications (including catheter blockage and cellulitis). However, patients in the TP group had more pleural procedures and relatively longer hospital stays. Additionally, no apparent difference was detected in QoL.ConclusionsTP has better pleurodesis rates, less total drainage, and fewer all-grade complications. However, TP has more pleural procedures and is not feasible for patients with trapped lungs. IPC has fewer further pleural interventions and shorter hospital stays. However, IPC has the nuisance of long-term in situ draining.
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:IntroductionNon-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).Methods and analysisConsecutive 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.Ethics and disseminationPre-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.Trial registration numberNCT03319186; Pre-results.
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.