Out Patient Talc Slurry Via Indwelling Pleural Catheter for Malignant Pleural Effusion Vs Usual Inpatient Management

Study Overview
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Brief Summary
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This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention

Official Title
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Randomised Controlled Trial Comparing Outpatient Management of Malignant Pleural Effusion Via an Indwelling Pleural Catheter and Talc Pleurodesis Versus Standard Inpatient Management in Improving Health Related Quality of Life

Conditions
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Pleural Effusion, Malignant

Intervention / Treatment
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* Device: Chest Drain Insertion and Talc Pleurodesis
* Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of malignant pleural effusion WHO performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage Expected survival greater than 3 months Exclusion Criteria: Age less than 18 years old Pregnant or lactating Known allergy to Talc or Lignocaine Lack of symptomatic relief from effusion drainage At least twice weekly drainage cannot be undertaken Lymphoma or small cell carcinoma except*: Failure of chemotherapy Deemed for palliative management Non malignant effusions Loculated pleural effusion Unable to provide written informed consent to trial participation

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>Patients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc | Device: Chest Drain Insertion and Talc Pleurodesis<br> <br> |
| Active Comparator: Indwelling Pleural Catheter Group<br>Patients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc | Device: Indwelling Pleural Catheter Insertion and Talc Pleurodesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global health-related quality of life | Global health related quality of life as measured by EORTC QLQ-C30 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global health-related quality of life |  | 60 and 90 days | 
| Pleurodesis failure rate | Subsequent pleural intervention required on same side as pleurodesis Chest X-ray opacification greater than 25% on side of intervention | 30, 60 and 90 days | 
| Improvement in symptoms of pain and breathlessness | Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness | 30, 60 and 90 days | 
| Complication rate | Clinical review and adverse event documentation | Day 7, 14, 30, 60 and 90 |