The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial
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 w...
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BMJ Publishing Group
2023-07-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/10/1/e001682.full |
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| author | Najib Rahman Rahul Bhatnagar Melissa Dobson Robert F Miller John E Harvey Emma Hedley Ramon Luengo-Fernandez Paul White Andrew Moore Anand Sundaralingam Lee Dobson Mohammed Munavvar Janet Mills Alexandra Dipper Emma Tucker Sandra Sowden |
| author_facet | Najib Rahman Rahul Bhatnagar Melissa Dobson Robert F Miller John E Harvey Emma Hedley Ramon Luengo-Fernandez Paul White Andrew Moore Anand Sundaralingam Lee Dobson Mohammed Munavvar Janet Mills Alexandra Dipper Emma Tucker Sandra Sowden |
| author_sort | Najib Rahman |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-23dc49ab074e479b960c028166c7a4ca |
| institution | DOAJ |
| issn | 2052-4439 |
| language | English |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj-art-23dc49ab074e479b960c028166c7a4ca2025-08-20T02:59:45ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392023-07-0110110.1136/bmjresp-2023-001682The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trialNajib Rahman0Rahul Bhatnagar1Melissa Dobson2Robert F Miller3John E Harvey4Emma Hedley5Ramon Luengo-Fernandez6Paul White7Andrew Moore8Anand Sundaralingam9Lee Dobson10Mohammed Munavvar11Janet Mills12Alexandra Dipper13Emma Tucker14Sandra Sowden15Oxford NIHR Biomedical Research Centre, Oxford, UKAcademic Respiratory Unit, University of Bristol, Bristol, UKOxford Respiratory Trials Unit, University of Oxford, Oxford, UKInstitute for Global Health, University College London, London, UKRespiratory Medicine, North Bristol NHS Trust, Bristol, UKOxford Respiratory Trials Unit, University of Oxford, Oxford, UKHealth Economics Research Centre, University of Oxford, Oxford, UKSchool of Data and Mathematics, University of the West of England, Bristol, UK2 Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, AustraliaOxford Respiratory Trials Unit, University of Oxford, Oxford, UKRespiratory Medicine, Royal Devon and Exeter NHS Foundation Trust Hospital, Exeter, UKRespiratory Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UKRespiratory Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UKAcademic Respiratory Unit, University of Bristol, Bristol, UKAcademic Respiratory Unit, University of Bristol, Bristol, UKRespiratory Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UKIntroduction 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.https://bmjopenrespres.bmj.com/content/10/1/e001682.full |
| spellingShingle | Najib Rahman Rahul Bhatnagar Melissa Dobson Robert F Miller John E Harvey Emma Hedley Ramon Luengo-Fernandez Paul White Andrew Moore Anand Sundaralingam Lee Dobson Mohammed Munavvar Janet Mills Alexandra Dipper Emma Tucker Sandra Sowden The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial BMJ Open Respiratory Research |
| title | The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial |
| title_full | The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial |
| title_fullStr | The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial |
| title_full_unstemmed | The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial |
| title_short | The randomised thoracoscopic talc poudrage+indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial (TACTIC): study protocol for a randomised controlled trial |
| title_sort | randomised thoracoscopic talc poudrage indwelling pleural catheters versus thoracoscopic talc poudrage only in malignant pleural effusion trial tactic study protocol for a randomised controlled trial |
| url | https://bmjopenrespres.bmj.com/content/10/1/e001682.full |
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