Malignant pleural effusion Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
1. Small-bore chest drain insertion followed by 4 g graded sterile talc slurry pleurodesis
2. Medical (local anaesthetic) thoracoscopy followed by 4 g graded sterile talc poudrage
Sponsors
North Bristol NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis, defined as: 1.1. Pleural effusion with histocytologically proven pleural malignancy OR 1.2. Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR 1.3. Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI) 2. Fit enough to undergo local anaesthetic thoracoscopy, as per British Thoracic Society (BTS) guidelines 3. Expected survival >3 months 4. Written, informed consent to trial participation
Exclusion criteria
Exclusion criteria: 1. Patients in whom thoracoscopy is the only reasonable approach to making a diagnosis, and in whom such a diagnosis would significantly influence further management 2. Age < 18 years 3. Females who are pregnant or lactating 4. Evidence of extensive lung entrapment on chest X-ray (CXR) or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis 5. Insufficient volume or position of pleural fluid on lateral decubitus thoracic ultrasound to safely perform local anaesthetic thoracoscopy without further intervention being necessary 6. Previously documented adverse reaction to talc 7. Clear contraindication to thoracoscopy or chest tube insertion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who experience pleurodesis failure up to three months (90 days) post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Requirement for further pleural procedures up to 6 months post-randomisation, as assessed by two independent, blinded adjudicators. The adjudicator will be provided with relevant radiological images and information regarding the patient's health status, including performance status and Visual Analogue Scores (VAS) scores for breathlessness and thoracic pain 2. Percentage radiographic (chest x-ray) pleural opacification, measured by visual estimation in a blinded fashion, on the side of the pleurodesis attempt at 24 hours post poudrage or slurry instillation, and at 3 and 6 months post randomisation 3. Self-reported health-related quality of life, as measured using the SF-36 and EQ-5D questionnaires measured at 1 month, 3 months and 6 months post randomisation 4. Self-reported thoracic pain, as measured using VAS scores recorded daily for the first 7 days post randomisation, and then weekly for the duration of trial follow-up 5. Self-reported breathlessness, as measured using VAS scores recorded daily for the first 7 days post randomisation, and then weekly for the duration of trial follow-up. 6. The number of patients with pleurodesis failure up to one month (30 days) post randomisation 7. The number of patients with pleurodesis failure up to six months (180 days) post randomisation 8. All-cause mortality up to six months (180 days) post-randomisation 9. Time to pleurodesis failure, censored at six months (180 days) post randomisation 10. Time from randomisation to hospital discharge 11. Number of days spent as a hospital inpatient up to three months 12. Healthcare resource usage and costs at six months (180 days) post randomisation 13. The costs of performing talc pleurodesis under the two interventions under study 14. Follow-up costs | — |
Countries
United Kingdom
Outcome results
None listed