Pleural effusion Respiratory Pleural effusion
Conditions
Interventions
Patients will be randomly assigned (1:1) to either an indwelling ambulatory pleural catheter or standard care for their malignant pleural effusion.
Computer derived allocation will be delivered by t
Sponsors
University of Oxford (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by: a. Histocytologically proven pleural malignancy or b. Recurrent large pleural effusion in the context of histologically proven cancer outside the thorax. 2. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Age < 18 years 2. Beginning chemotherapy in the next 4 weeks 3. Expected survival <3 months 4. Chylothorax 5. Previous lobectomy or pneumonectomy on the side of the effusion 6. Previous attempted pleurodesis 7. Pleural infection 8. Total blood white cell count <1.0 x 109 9. Hypercapnic ventilatory failure 10. Patients who are pregnant or lactating 11. Irreversible bleeding diathesis 12. Irreversible visual impairment 13. Inability to give informed consent or comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the average daily Visual Analogue Scale (VAS) defining breathlessness, after removing "breathlessness unresponsive to pleural fluid drainage" - defined as the VAS following first complete pleural fluid drainage. Patients will also record how much their breathlessness has bothered them each day. The daily VAS will be performed at a similar time each day. The patients will perform VAS and record breathlessness for 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at time of the primary outcome measure and recorded throughout the year of the trial: 1. Average daily chest pain assessed using VAS score for 6 weeks 2. Self reported health status (?quality of life?) assessed using Chronic Respiratory Disease Questionnaire (CRDQ) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) 3. Economic assessment: direct quantification of clinical costs from patient kept diary records and estimated health care costs (Euroqol-5 Dimensions [EQ-5D] Questionnaire) 4. Spontaneous pleurodesis rate with ambulatory catheters (This will differ for each patient and will be recorded individually) 5. Complication rate with ambulatory catheters (Any complications that arise will be documented throughout the duration of the study) | — |
Countries
United Kingdom
Outcome results
None listed