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Evaluating the efficacy of thoracoscopy and talc poudrage versus pleurodesis using talc slurry ( TAPPS trial ) : protocol of an open-label randomised controlled trial . INTRODUCTION The 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 ANALYSIS 330 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 DISSEMINATION The 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 NUMBER ISRCTN47845793 .
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Intervention_Surgical
thoracoscopy
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Intervention_Physical
talc poudrage
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Intervention_Physical
pleurodesis using talc slurry
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Intervention_Physical
talc pleurodesis
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Intervention_Pharmacological
Talc
68750
Intervention_Surgical
medical thoracoscopy using poudrage
68751
Intervention_Surgical
medical thoracoscopy
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Intervention_Physical
talc poudrage
68753
Intervention_Surgical
chest drain insertion
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Intervention_Pharmacological
talc slurry
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Outcome_Other
efficacy
68756
Outcome_Physical
measure is pleurodesis failure
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Outcome_Physical
Pleurodesis
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Participant_Sample-size
330