Abstract
INTRODUCTION: Malignant pleural effusion (MPE) is common, with 50 000 new cases per year in the UK. MPE causes disabling breathlessness and indicates advanced disease with a poor prognosis. Treatment approaches focus on symptom relief and optimising quality of life (QoL). Patients who newly present with MPE commonly require procedural intervention for both diagnosis and therapeutic benefit.Thoracoscopic pleural biopsies are highly sensitive in diagnosing pleural malignancy. Talc poudrage may be delivered at thoracoscopy (TTP) to prevent effusion recurrence by effecting pleurodesis. Indwelling pleural catheters (IPCs) offer an alternative strategy for fluid control, enabling outpatient management and are often used as 'rescue' therapy following pleurodesis failure or in cases of 'trapped lung'. It is unknown whether combining a TTP with IPC insertion will improve patient symptoms or reduce time spent in the hospital.The randomised thoracoscopic talc poudrage + indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC) is the first randomised controlled trial (RCT) to examine the benefit of a combined TTP and IPC procedure, evaluating cost-effectiveness and patient-centred outcomes such as symptoms and QoL. The study remains in active recruitment and has the potential to radically transform the pathway for all patients presenting with MPE.
METHODS AND ANALYSIS: TACTIC is an unblinded, multicentre, RCT comparing the combination of TTP with an IPC to TTP alone. Co-primary outcomes are time spent in the hospital and mean breathlessness score over 4 weeks postprocedure. The study will recruit 124 patients and aims to define the optimal pathway for patients presenting with symptomatic MPE.
ETHICS AND DISSEMINATION: TACTIC is sponsored by North Bristol NHS Trust and has been granted ethical approval by the London-Brent Research Ethics Committee (REC ref: 21/LO/0495). Publication of results in a peer-reviewed journal and conference presentations are anticipated.
TRIAL REGISTRATION: ISRCTN 11058680.
| Original language | English |
|---|---|
| Article number | e001682 |
| Number of pages | 8 |
| Journal | BMJ Open Respiratory Research |
| Volume | 10 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 30 May 2023 |
Bibliographical note
Funding Information:The authors would like to acknowledge and are grateful for the ongoing contributions of the medical, nursing and administrative teams at all the TACTIC recruitment centres. In addition to the listed authors, this manuscript has been reviewed by Mark Slade, independent TSC member. This study is supported by Rocket Medical who have supplied IPCs and drainage bottles. There has been no commercial involvement in the conception, design, delivery or management of the study, the protocol, the statistical analysis plan or the dissemination plan.
Publisher Copyright:
© 2023 BMJ Publishing Group. All rights reserved.
Research Groups and Themes
- Academic Respiratory Unit
Keywords
- Humans
- Pleural Effusion, Malignant/etiology
- Talc/therapeutic use
- Catheters, Indwelling/adverse effects
- Pleura
- Dyspnea/etiology
- Randomized Controlled Trials as Topic
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Optimising the management of malignant pleural effusion
Dipper, A. S. L. (Author), Maskell, N. (Supervisor) & Bhatnagar, R. (Supervisor), 18 Jun 2024Student thesis: Doctoral Thesis › Doctor of Philosophy (PhD)
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