None listed
Conditions
Brief summary
This study is a multicentre randomized clinical trial aiming to evaluate the potential benefits of employing indwelling small-bore pleural catheters (IPCs) as first-line management of malignant pleural effusion, especially in reducing the need of inpatient hospital care for these patients. The study also evaluates the adverse event rates, health costs and acceptability of this new management option to patients and clinicians. Who is it for? You may be eligible for this study if you are over 18 years of age and have been diagnosed with a Symptomatic Malignant Pleural Effusion Trial Details: Participants in this study will be randomized to one of two treatment arms: either Indwelling Pleural Catheter (IPC) or Talc Pleurodesis. IPC involves a soft, flexible, silicon catheter placed in the pleural space and tunnelled through the subcutaneous tissues, administered under light sedation and local anaesthesia - often in a Day Procedure Unit with you being discharged home after just a few hours. The insertion of the catheter will allow simple, painless drainage of effusions which may end up with you needing to visit hospital less often. They are designed to remain in your chest for the rest of your life, but around 40% of patients are able to have the IPC removed because of spontaneous pleurodesis (a benefit of the IPC treatment in keeping the pleural space dry). Talc pleurodesis is a conventional, inpatient procedure performed at the bedside. It takes an average of 6 days in hospital. A small bore chest drain is inserted, the fluid is completely drained away, and then talc is injected into the pleural space. Pleurodesis has a 60-80% chance of successfully preventing the need for further pleural drainage.
Interventions
Indwelling Pleural Catheter (IPC): A soft flexible silicon catheter placed in the pleural space and tunnelled through the subcutaneous tissues. It is anchored by a cuff in the subcutaneous segment into which fibroblasts grow. IPCs are inserted under light sedation and local anaesthesia, often in a Day Procedure Unit being discharged home after just a few hours. They allow simple, painless ambulatory drainage of effusions, averting hospital attendances. They are designed to remain in situ for the remainder of the patient's life, but around 40% of patients are able to have the IPC removed because of spontaneous pleurodesis (a benefit of the IPC treatment keeping the pleural space dry).
Sponsors
Study design
Eligibility
Inclusion criteria
Symptomatic Malignant Pleural Effusion
Exclusion criteria
Age <18 years; an effusion <2cm at maximum depth; expected survival <3 months; chylothorax; previous ipsilateral lobectomy or pneumonectomy; previous attempted pleurodesis; pleural infection; leukocytopenia (<1.0x109/L); pregnant or lactating patients; uncorrectable bleeding diathesis; inability to give informed consent or comply with the protocol.