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Randomized Controlled Trial
. 2020 Jan 7;323(1):60-69.
doi: 10.1001/jama.2019.19997.

Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial

Rahul Bhatnagar  1   2 , Hania E G Piotrowska  3 , Magda Laskawiec-Szkonter  3 , Brennan C Kahan  4 , Ramon Luengo-Fernandez  5 , Justin C T Pepperell  6 , Matthew D Evison  7 , Jayne Holme  7 , Mohamed Al-Aloul  7 , Ioannis Psallidas  8 , Wei Shen Lim  9   10 , Kevin G Blyth  11   12 , Mark E Roberts  13 , Giles Cox  13 , Nicola J Downer  13 , Jurgen Herre  14 , Pasupathy Sivasothy  14 , Daniel Menzies  15 , Mohammed Munavvar  16 , Moe M Kyi  17 , Liju Ahmed  18 , Alex G West  18 , Richard N Harrison  19 , Benjamin Prudon  19 , Gihan Hettiarachchi  20 , Biswajit Chakrabarti  21 , Ajikumar Kavidasan  22   23 , Benjamin P Sutton  24 , Natalie J Zahan-Evans  1   2 , Jack L Quaddy  3 , Anthony J Edey  2 , Amelia O Clive  1   2 , Steven P Walker  1   2 , Matthew H R Little  5 , Xue W Mei  5 , John E Harvey  2 , Clare E Hooper  25 , Helen E Davies  26 , Mark Slade  27 , Merle Sivier, Robert F Miller  28 , Najib M Rahman  3 , Nick A Maskell  1   2
Affiliations
Randomized Controlled Trial

Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial

Rahul Bhatnagar et al. JAMA. .

Abstract

Importance: Malignant 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.

Objective: To 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 participants: Open-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.

Interventions: Patients 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 measures: The 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.

Results: Among 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 relevance: Among 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 registration: ISRCTN Identifier: ISRCTN47845793.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Maskell reported receiving grants and personal fees from Beckton Dickinson (BD), grants from Rocket Medical, and personal fees from Cook Medical outside the submitted work. Dr Ahmed reported receiving grants from BD and Rostrees Charity Trust outside the submitted work. Dr Blyth reported receiving grants from Rocket Medical UK Ltd outside the submitted work. Dr Miller reported receiving personal fees from Gilead outside the submitted work. Dr Psallidas reported serving as a medical science director for AstraZeneca in a field unrelated to pleural diseases. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow of Patients in a Study of the Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions
Figure 2.
Figure 2.. Pleurodesis Failure Within 180 Days After Randomization in a Study of the Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions
The primary outcome analysis took place 90 days after randomization. At this point, 36 of 161 patients (22%) in the talc poudrage group had pleurodesis failure compared with 38 of 159 (24%) in the talc slurry group (adjusted odds ratio [OR], 0.91 [95% CI, 0.54-1.55]; P = .74). At 180 days, failure rates were 46 of 161 patients (29%) in the talc poudrage group and 44 of 159 (28%) in the talc slurry group (OR, 1.05 [95% CI, 0.63-1.73]; P = .86).
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References

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