Malignant pleural effusion (MPE) Respiratory
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Symptomatic unilateral (or bilateral if one side dominates) pleural effusion AND any of the following* 1.1. Suspicion of malignant cause based on imaging features on CT or ultrasound 1.2. Previous proven diagnosis of extrapleural malignancy 1.3. Lack of alternative likely clinical diagnosis such as infection or heart failure (as judged by local PI) 2. Sufficient pleural effusion size as determined on ultrasound to require therapeutic pleural drainage 3. Participant is willing and able to give informed consent for participation in the trial. 4. Male or Female, aged 18 years or above. *The above features will be assessed by the local recruiting clinician, and judgments on likely clinical diagnosis and the imaging features will be conducted by local recruiting clinicians to remain pragmatic.
Exclusion criteria
Exclusion criteria: 1. Technically unable to undergo pleural biopsy and indwelling pleural catheter (e.g. gross respiratory failure, uncorrectable clotting, unable to tolerate position, poor performance status (WHO performance status 3 or worse when accounting for the effusion)). 2. Visual impairment (precluding use of symptom measurement instruments 3. Previous talc pleurodesis within the last 3 months on ipsilateral side. 4. No means of phone contact 5. Age < 18 years 6. Females who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of recruitment measured using patient records at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness as measured by 100mm VAS score weekly for 6 weeks post intervention (trial procedure) 2. Health Related Quality of Life (EQ-5D) weekly for 6 weeks post intervention (trial procedure) 3. Patient Anxiety and Depression (HADS) weekly for 6 weeks post intervention (trial procedure) 4. Time to actionable histopathology/diagnosis measured using patient records throughout the study 5. Healthcare utilisation measured using patient records until end of recruitment | — |
Countries
England, United Kingdom