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S36 The streamline feasibility randomised clinical trial (early pleural biopsy + indwelling pleural catheter in suspected malignant pleural effusion)

thoraxjnl · 2025-11-02 · canonical JSON source

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Introduction Malignant pleural effusion (MPE) affects 50 000 patients per year in the UK. Patients with MPE require multiple pleural procedures with prolonged time to diagnosis and fluid control. Thoracocentesis remains the guideline based first intervention in MPE, but has poor sensitivity and molecular completion and does not prevent effusion recurrence. This paradigm has not been challenged in over 40 years – we therefore co-created an accelerated pathway with and for patients with suspected MPE, with the aim of reducing symptom duration and number of procedures to diagnosis and definitive management.Aims To assess feasibility of recruitment to a randomised trial comparing standard care (1st procedure thoracocentesis) vs accelerated pathway (1st procedure pleural biopsy + IPC) in suspected MPE.Methods STREAMLINE was a UK NIHR funded multi-centre trial, opened to recruitment in January 2024. Patients were randomised 1:1 between standard care and accelerated pathways. Key eligibility criteria include: pleural effusion requiring therapeutic drainage, with suspicion of malignant cause based on imaging or history of cancer. The primary outcome was feasibility of recruitment, with key secondary outcomes including breathlessness (100 mm VAS) over 6 weeks from first procedure, quality of life (QLQ-C30), time to treatable diagnosis and adverse events.Results The STREAMLINE protocol was co-created with MPE patients and expert pleural clinicians to ensure emphasis on patient and healthcare priorities. Target recruitment was completed (n=40) in June 2025. Full results including the effect on diagnostic time and symptoms will be available and presented at the Winter BTS meeting if accepted.Conclusion The STREAMLINE feasibility trial will determine whether a novel direct to pleural biopsy + IPC approach is deliverable within the NHS and assess whether the accelerated pathway improves breathlessness and time to diagnosis, including molecular completion. 6 week follow up will be completed in August 2025 and results presented at the BTS contingent on selection. The results could lead to a paradigm shift in pleural management within UK healthcare systems.