A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions

Inclusion criteria

• Subject is ≥ 18 years old.
• Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:

• There is histocytological confirmation of pleural malignancy
• The effusion is an exudate (as per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
• Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.
• Subject is willing and able to provide written informed consent.
• Subject is willing and able to meet all study requirements, including attending follow-up visits or receiving trial-related telephone calls.
• There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
• Negative pregnancy test if appropriate

Exclusion criteria

• Subject has significant trapped lung (>20%), or a proximal bronchial obstruction which is likely to lead to trapped lung.
• Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3* or more.
• Subject is pregnant, planning to become pregnant, or is lactating.
• Subject has a history of empyema.
• Subject has a history of chylothorax.
• Subject has an uncorrected coagulopathy.
• Subject is allergic to device materials.
• Subject has evidence, in the opinion of the Chief Investigator, of either on-going systemic or pleural infection.
• Subject has had a lobectomy or pneumonectomy on the side of the effusion.
• Subject has undergone a previous attempt at pleurodesis which has failed.
• Subject has previously been diagnosed with a serious immunodeficiency disorder.
• Subject has bilateral pleural effusions, with both being at least moderate in size (greater than 1/3 of the hemithorax on chest x-ray).
• Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.
• Subject has a mediastinal shift of ≥2cm toward the side of the effusion.
• Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest.
• Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Chief Investigator, would mean participation in the study would be contraindicated.
• Subject has no access to a telephone
• No details of blood values (full blood count, clotting screen, urea and electrolytes, liver function) from within the last 10 days * Patients who have a performance status of 3 may be considered for the trial if the removal of their fluid would likely improve their performance score by 1 or more.