Rahul Bhatnagar1, Emma K Keenan1, Anna J Morley1, Brennan C Kahan1, Andrew E Stanton1, Mohammed Haris1, Richard N Harrison1, Rehan A Mustafa1, Lesley J Bishop1, Liju Ahmed1, Alex West1, Jayne Holme1, Matthew Evison1, Mohammed Munavvar1, Pasupathy Sivasothy1, Jurgen Herre1, David Cooper1, Mark Roberts1, Anur Guhan1, Clare Hooper1, James Walters1, Tarek S Saba1, Biswajit Chakrabarti1, Samal Gunatilake1, Ioannis Psallidas1, Steven P Walker1, Anna C Bibby1, Sarah Smith1, Louise J Stadon1, Natalie J Zahan-Evans1, Y C Gary Lee1, John E Harvey1, Najib M Rahman1, Robert F Miller1, Nick A Maskell1. 1. From the Academic Respiratory Unit, University of Bristol (R.B., S.P.W., A.C.B., N.A.M.), and North Bristol NHS Trust (R.B., E.K.K., A.J.M., S.P.W., A.C.B., S.S., L.J.S., N.J.Z.-E., J.E.H., N.A.M.), Bristol, the Pragmatic Clinical Trials Unit, Queen Mary University of London (B.C.K.), Guy's and St. Thomas' NHS Foundation Trust (L.A., A.W.), King's College School of Medicine, King's College University (L.A.), and the Institute for Global Health, University College London (R.F.M.), London, Great Western Hospitals NHS Foundation Trust, Swindon (A.E.S.), University Hospital of North Midlands NHS Trust, Stoke-on-Trent (M.H.), the School of Medicine, Keele University, Newcastle-under-Lyme (M.H.), North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (R.N.H.), South Tees Hospitals NHS Foundation Trust, Middlesbrough (R.A.M.), Portsmouth Hospitals NHS Trust, Portsmouth (L.J.B.), Manchester University NHS Foundation Trust, Manchester (J. Holme, M.E.), Lancashire Teaching Hospitals NHS Foundation Trust, Preston (M.M.), Cambridge University Hospitals NHS Foundation Trust, Cambridge (P.S., J. Herre), Northumbria Healthcare NHS Foundation Trust, North Shields (D.C.), Sherwood Forest Hospitals NHS Foundation Trust, Sutton-in-Ashfield (M.R.), NHS Ayrshire and Arran, Ayr (A.G.), Worcester Acute Hospitals NHS Trust, Worcester (C.H.), Royal United Hospitals Bath NHS Foundation Trust, Bath (J.W.), Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool (T.S.S.), Aintree University Hospitals NHS Foundation Trust, Liverpool (B.C.), Hampshire Hospitals NHS Foundation Trust, Winchester (S.G.), and the Oxford Respiratory Trials Unit, University of Oxford (I.P., N.M.R.), the Oxford University Hospitals NHS Foundation Trust (I.P., N.M.R.), and the Oxford NIHR Biomedical Research Centre (N.M.R.), Oxford - all in the United Kingdom; and the Institute for Respiratory Health, University of Western Australia, and Sir Charles Gairdner Hospital, Perth, WA, Australia (Y.C.G.L.).
Abstract
BACKGROUND: Malignant pleural effusion affects more than 750,000 persons each year across Europe and the United States. Pleurodesis with the administration of talc in hospitalized patients is the most common treatment, but indwelling pleural catheters placed for drainage offer an ambulatory alternative. We examined whether talc administered through an indwelling pleural catheter was more effective at inducing pleurodesis than the use of an indwelling pleural catheter alone. METHODS: Over a period of 4 years, we recruited patients with malignant pleural effusion at 18 centers in the United Kingdom. After the insertion of an indwelling pleural catheter, patients underwent drainage regularly on an outpatient basis. If there was no evidence of substantial lung entrapment (nonexpandable lung, in which lung expansion and pleural apposition are not possible because of visceral fibrosis or bronchial obstruction) at 10 days, patients were randomly assigned to receive either 4 g of talc slurry or placebo through the indwelling pleural catheter on an outpatient basis. Talc or placebo was administered on a single-blind basis. Follow-up lasted for 70 days. The primary outcome was successful pleurodesis at day 35 after randomization. RESULTS: The target of 154 patients undergoing randomization was reached after 584 patients were approached. At day 35, a total of 30 of 69 patients (43%) in the talc group had successful pleurodesis, as compared with 16 of 70 (23%) in the placebo group (hazard ratio, 2.20; 95% confidence interval, 1.23 to 3.92; P=0.008). No significant between-group differences in effusion size and complexity, number of inpatient days, mortality, or number of adverse events were identified. No significant excess of blockages of the indwelling pleural catheter was noted in the talc group. CONCLUSIONS: Among patients without substantial lung entrapment, the outpatient administration of talc through an indwelling pleural catheter for the treatment of malignant pleural effusion resulted in a significantly higher chance of pleurodesis at 35 days than an indwelling catheter alone, with no deleterious effects. (Funded by Becton Dickinson; EudraCT number, 2012-000599-40 .).
RCT Entities:
BACKGROUND:Malignant pleural effusion affects more than 750,000 persons each year across Europe and the United States. Pleurodesis with the administration of talc in hospitalized patients is the most common treatment, but indwelling pleural catheters placed for drainage offer an ambulatory alternative. We examined whether talc administered through an indwelling pleural catheter was more effective at inducing pleurodesis than the use of an indwelling pleural catheter alone. METHODS: Over a period of 4 years, we recruited patients with malignant pleural effusion at 18 centers in the United Kingdom. After the insertion of an indwelling pleural catheter, patients underwent drainage regularly on an outpatient basis. If there was no evidence of substantial lung entrapment (nonexpandable lung, in which lung expansion and pleural apposition are not possible because of visceral fibrosis or bronchial obstruction) at 10 days, patients were randomly assigned to receive either 4 g of talc slurry or placebo through the indwelling pleural catheter on an outpatient basis. Talc or placebo was administered on a single-blind basis. Follow-up lasted for 70 days. The primary outcome was successful pleurodesis at day 35 after randomization. RESULTS: The target of 154 patients undergoing randomization was reached after 584 patients were approached. At day 35, a total of 30 of 69 patients (43%) in the talc group had successful pleurodesis, as compared with 16 of 70 (23%) in the placebo group (hazard ratio, 2.20; 95% confidence interval, 1.23 to 3.92; P=0.008). No significant between-group differences in effusion size and complexity, number of inpatient days, mortality, or number of adverse events were identified. No significant excess of blockages of the indwelling pleural catheter was noted in the talc group. CONCLUSIONS: Among patients without substantial lung entrapment, the outpatient administration of talc through an indwelling pleural catheter for the treatment of malignant pleural effusion resulted in a significantly higher chance of pleurodesis at 35 days than an indwelling catheter alone, with no deleterious effects. (Funded by Becton Dickinson; EudraCT number, 2012-000599-40 .).
Authors: Rahul Bhatnagar; Ramon Luengo-Fernandez; Brennan C Kahan; Najib M Rahman; Robert F Miller; Nick A Maskell Journal: Health Technol Assess Date: 2020-06 Impact factor: 4.014
Authors: Pranav Murthy; Chigozirim N Ekeke; Kira L Russell; Samuel C Butler; Yue Wang; James D Luketich; Adam C Soloff; Rajeev Dhupar; Michael T Lotze Journal: Oncoimmunology Date: 2019-01-22 Impact factor: 8.110
Authors: Ala-Eddin S Sagar; Daniel L Dodge; Moiz Salahuddin; Mark T Warner; Garbo Mak; Saadia A Faiz Journal: Am J Respir Crit Care Med Date: 2019-09-15 Impact factor: 21.405
Authors: Paul J Halford; Rahul Bhatnagar; Paul White; Mohammed Haris; Richard N Harrison; Jayne Holme; Pasupathy Sivasothy; Alex West; Lesley J Bishop; Andrew E Stanton; Mark Roberts; Clare Hooper; Nick A Maskell Journal: J Thorac Dis Date: 2020-04 Impact factor: 2.895