Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management

Study Overview
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Brief Summary
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Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about 300,000 patients annually (UK and USA). Lung and breast cancers account for majority of malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as > 90% of patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling and impairs quality of life. Median survival ranges between 4-6 months. Although thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy, and talc is the most effective agent. For successful pleurodesis to occur the underlying lung must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%. Symptomatic patients require hospitalization for these procedures which are likely to fail if trapped lungs are encountered, and pose significant burden to health services. Tunneled indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at ambulatory setting without hospital admission. Case series have demonstrated long-term safety of IPC even in patients undergoing chemotherapy with acceptable complication rates. By keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in hospitalizations, adverse events and healthcare costs, and if it improves quality of life. The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc pleurodesis, and endpoints include hospitalization days till death or end of study, adverse events, quality of life, and healthcare costs.

Official Title
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A Multicentre Randomised Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis in Patients With a Malignant Pleural Effusion

Conditions
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Pleural Effusion, Malignant

Intervention / Treatment
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* Device: Indwelling Pleural Catheter
* Procedure: Talc Pleurodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic malignant pleural effusion requiring intervention Exclusion Criteria: <18 years of age pregnant or lactating patients expected survival <3 months chylothorax previous attempted pleurodesis pleural infection leukocytopaenia (<1.0 x 10^9/L) uncorrectable bleeding diathesis inability to give informed consent or comply with the protocol

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indwelling Pleural Catheter<br>Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care. | Device: Indwelling Pleural Catheter<br> <br> |
| Active Comparator: Talc Pleurodesis<br>Hospital admission for chest drain insertion and suction if needed, plus talc pleurodesis by slurry or poudrage if >75% of visceral and parietal pleura in direct contact on chest x-ray. | Procedure: Talc Pleurodesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital days for all causes following intervention |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital days computed for pleural effusion related cause |  | Up to 1 year | 
| Number of adverse events |  | Up to 1 year | 
| Breathlessness score |  | Up to 1 year | 
| Self-reported quality of life scores |  | Up to 1 year | 
| Health costs computation |  | Up to 1 year |