title: The efficacy of indwelling pleural catheter placement versus placement plus talc sclerosant in patients with malignant pleural effusions managed exclusively as outpatients (IPC-PLUS): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Malignant pleural effusions (MPEs) remain a common problem, with 40,000 new cases in the United Kingdom each year and up to 250,000 in the United States. Traditional management of MPE usually involves an inpatient stay with placement of a chest drain, followed by the instillation of a pleural sclerosing agent such as talc, which aims to minimise further fluid build-up. Despite a good success rate in studies, this approach can be expensive, time-consuming and inconvenient for patients. More recently, an alternative method has become available in the form of indwelling pleural catheters (IPCs), which can be inserted and managed in an outpatient setting. It is currently unknown whether combining talc pleurodesis with IPCs will provide improved pleural symphysis rates over those of IPCs alone.
  
  
  METHODS
  IPC-PLUS is a patient-blind, multicentre randomised controlled trial (RCT) comparing the combination of talc with an IPC to the use of an IPC alone for inducing pleurodesis in MPEs. The primary outcome is successful pleurodesis at five weeks post-randomisation. This study will recruit 154 patients, with an interim analysis for efficacy after 100 patients, and aims to help to define the future gold standard for outpatient management of patients with symptomatic MPEs.
  
  
  CONCLUSIONS
  IPC-PLUS is the first RCT to examine the practicality and utility of talc administered via an IPC. The study remains in active recruitment and has the potential to significantly alter how patients requiring pleurodesis for MPE are approached in the future.
  
  
  BACKGROUND
  This trial was registered with Current Controlled Trials (identifier: ISRCTN73255764 ) on 23 August 2012.
authors.affiliation: Academic Respiratory Unit, University of Bristol, Southmead Hospital, Learning and Research Building, Southmead Road, Bristol, BS10 5NB, UK. Rahul.Bhatnagar@bristol.ac.uk.|Respiratory Research, Clinical Research Centre, Southmead Hospital, Southmead Road, Bristol, BS10 5NB, UK. Rahul.Bhatnagar@bristol.ac.uk.
authors.forename: Rahul
authors.initials: R
authors.lastname: Bhatnagar
authors.affiliation: Pragmatic Clinical Trials Unit, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK. B.Kahan@qmul.ac.uk.
authors.forename: Brennan C
authors.initials: BC
authors.lastname: Kahan
authors.affiliation: Academic Respiratory Unit, University of Bristol, Southmead Hospital, Learning and Research Building, Southmead Road, Bristol, BS10 5NB, UK. Anna.Morley@nbt.nhs.uk.|Respiratory Research, Clinical Research Centre, Southmead Hospital, Southmead Road, Bristol, BS10 5NB, UK. Anna.Morley@nbt.nhs.uk.
authors.forename: Anna J
authors.initials: AJ
authors.lastname: Morley
authors.affiliation: Academic Respiratory Unit, University of Bristol, Southmead Hospital, Learning and Research Building, Southmead Road, Bristol, BS10 5NB, UK. Emma.Keenan@nbt.nhs.uk.|Respiratory Research, Clinical Research Centre, Southmead Hospital, Southmead Road, Bristol, BS10 5NB, UK. Emma.Keenan@nbt.nhs.uk.
authors.forename: Emma K
authors.initials: EK
authors.lastname: Keenan
authors.affiliation: Research Department of Infection and Population Health, Institute of Epidemiology and Healthcare, University College London, 222 Euston Road, London, NW1 2DA, UK. Robert.Miller@ucl.ac.uk.|Clinical Research Department, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Robert.Miller@ucl.ac.uk.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Miller
authors.affiliation: Oxford Centre for Respiratory Medicine, Churchill Hospital, Old Road, Oxford, OX3 7LE, UK. Najib.Rahman@ouh.nhs.uk.|Oxford Respiratory Trials Unit, University of Oxford, Churchill Hospital, Old Road, Oxford, OX3 7LE, UK. Najib.Rahman@ouh.nhs.uk.
authors.forename: Najib M
authors.initials: NM
authors.lastname: Rahman
authors.affiliation: Academic Respiratory Unit, University of Bristol, Southmead Hospital, Learning and Research Building, Southmead Road, Bristol, BS10 5NB, UK. Nick.Maskell@bristol.ac.uk.|Respiratory Research, Clinical Research Centre, Southmead Hospital, Southmead Road, Bristol, BS10 5NB, UK. Nick.Maskell@bristol.ac.uk.
authors.forename: Nick A
authors.initials: NA
authors.lastname: Maskell
mesh_terms: D002408:Catheters, Indwelling; D002985:Clinical Protocols; D003625:Data Collection; D003627:Data Interpretation, Statistical; D006801:Humans; D016066:Pleural Effusion, Malignant / Q000628:therapy*; D018401:Sample Size; D012597:Sclerosing Solutions / Q000627:therapeutic use*; D013627:Talc; D064232:Visual Analog Scale
chemical_list: D012597:Sclerosing Solutions; D013627:Talc