IPC-PLUS Trial

• Research type

  Research Study

• Full title

  The efficacy of Indwelling Pleural Catheter placement versus IPC placement PLUS sclerosant (talc) in patients with malignant pleural effusions managed exclusively as out-patients

• IRAS ID

  94768

• Contact name

  Nick Maskell

• Sponsor organisation

  North Bristol NHS Trust

• Eudract number

  2012-000599-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Many types of cancer can affect the lining of the lung (the pleura). When this happenflud can build up between the pleura which can then compress the underlying lung, causing breathlessness. The management of this malignant pleuraflud, or effusion, can be difficult as there is often a tendency for it to recur. Traditional management of malignant effusions involves inserting a chest tube into thflud to allow it to be drained away. Once this is done an irritant substance such as sterile talc is inserted through the tube. This causes inflammation, which in turn causes the pleura to stick together, preventing furtheflud build-up. This is called pleurodesis. Although successful in about 85% of cases, this method can be cumbersome for patients and often involves a hospital stay of up to a week. A more recent development is the indwelling pleural catheter (IPC). This type of chest tube is inserted as a day case procedure, and is tunneled under the skin to reduce the risk of infection. Once in place, anflud which builds up can be tapped off in the patient??s own home. This approach is generally more convenient for patients and can also lead to pleurodesis, although the rates for this are lower than with talc at around 50%. The IPC-PLUS trial aims to determine the optimum management of patients with malignant pleural effusions by using a combination of both IPC and talc for the first time. We shall compare pleurodesis rates, as well as patients?? quality of life and breathlessness, with those treated with an IPC and an inert placebo. Although this study will look at patients from the UK, the results will be applicable globally and may help to change the way in which malignant pleural effusions are cared for.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0242

• Date of REC Opinion

  24 May 2012

• REC opinion

  Further Information Favourable Opinion