• Rahul Bhatnagar, Piotrowska Hania E G HEG Oxford Respiratory Trials Unit, Nuffield Department of Experimental Medicine, University of Oxford, United Kingdom., Magda Laskawiec-Szkonter, Brennan C Kahan, Ramon Luengo-Fernandez, Pepperell Justin C T JCT Somerset Lung Centre, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, United Kingdom., Matthew D Evison, Jayne Holme, Mohamed Al-Aloul, Ioannis Psallidas, Wei Shen Lim, Kevin G Blyth, Mark E Roberts, Giles Cox, Nicola J Downer, Jurgen Herre, Pasupathy Sivasothy, Daniel Menzies, Mohammed Munavvar, Moe M Kyi, Liju Ahmed, Alex G West, Richard N Harrison, Benjamin Prudon, Gihan Hettiarachchi, Biswajit Chakrabarti, Ajikumar Kavidasan, Benjamin P Sutton, Natalie J Zahan-Evans, Jack L Quaddy, Anthony J Edey, Amelia O Clive, Steven P Walker, Matthew H R Little, Xue W Mei, John E Harvey, Clare E Hooper, Helen E Davies, Mark Slade, Merle Sivier, Robert F Miller, Najib M Rahman, and Nick A Maskell.
• Academic Respiratory Unit, University of Bristol, Bristol, United Kingdom.
• JAMA. 2020 Jan 7; 323 (1): 60-69.

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.

16 keywords...

hide…