title: Evaluating the efficacy of thoracoscopy and talc poudrage versus pleurodesis using talc slurry (TAPPS trial): protocol of an open-label randomised controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  ISRCTN47845793.
authors.affiliation: Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK Academic Respiratory Unit, University of Bristol, Bristol, UK.
authors.forename: Rahul
authors.identifier: http://orcid.org/0000-0003-3906-1997
authors.initials: R
authors.lastname: Bhatnagar
authors.affiliation: Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.
authors.forename: Magda
authors.initials: M
authors.lastname: Laskawiec-Szkonter
authors.affiliation: Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.
authors.forename: Hania E G
authors.initials: HE
authors.lastname: Piotrowska
authors.affiliation: Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.
authors.forename: Brennan C
authors.initials: BC
authors.lastname: Kahan
authors.affiliation: Respiratory Department, Worcestershire Royal Hospital, Worcester, UK.
authors.forename: Clare E
authors.initials: CE
authors.lastname: Hooper
authors.affiliation: Cardiff and Vale University Health Board, Cardiff, Wales, UK.
authors.forename: Helen E
authors.initials: HE
authors.lastname: Davies
authors.affiliation: Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK Academic Respiratory Unit, University of Bristol, Bristol, UK.
authors.forename: John E
authors.initials: JE
authors.lastname: Harvey
authors.affiliation: Research Department of Infection and Population Health, Institute of Epidemiology and Healthcare, University College London, London, UK Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Miller
authors.affiliation: Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK Oxford Centre for Respiratory Medicine, Churchill Hospital, Oxford, UK.
authors.forename: Najib M
authors.initials: NM
authors.lastname: Rahman
authors.affiliation: Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK Academic Respiratory Unit, University of Bristol, Bristol, UK.
authors.forename: Nick A
authors.initials: NA
authors.lastname: Maskell
mesh_terms: D015505:Chest Tubes; D004322:Drainage / Q000379:methods; D006801:Humans; D016066:Pleural Effusion, Malignant / Q000628:therapy*; D018700:Pleurodesis / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D013627:Talc / Q000008:administration & dosage / Q000627:therapeutic use*; D013906:Thoracoscopy / Q000379:methods*; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D013627:Talc
keywords: Malignant pleural effusion; Pleurodesis; Randomised controlled trial; Talc