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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...

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Autores principales: Dipper, Alexandra, Sundaralingam, Anand, Hedley, Emma, Tucker, Emma, White, Paul, Bhatnagar, Rahul, Moore, Andrew, Dobson, Melissa, Luengo-Fernandez, Ramon, Mills, Janet, Sowden, Sandra, Harvey, John E, Dobson, Lee, Miller, Robert F, Munavvar, Mohammed, Rahman, Najib, Maskell, Nick
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10230980/
https://www.ncbi.nlm.nih.gov/pubmed/37253535
http://dx.doi.org/10.1136/bmjresp-2023-001682
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author Dipper, Alexandra
Sundaralingam, Anand
Hedley, Emma
Tucker, Emma
White, Paul
Bhatnagar, Rahul
Moore, Andrew
Dobson, Melissa
Luengo-Fernandez, Ramon
Mills, Janet
Sowden, Sandra
Harvey, John E
Dobson, Lee
Miller, Robert F
Munavvar, Mohammed
Rahman, Najib
Maskell, Nick
author_facet Dipper, Alexandra
Sundaralingam, Anand
Hedley, Emma
Tucker, Emma
White, Paul
Bhatnagar, Rahul
Moore, Andrew
Dobson, Melissa
Luengo-Fernandez, Ramon
Mills, Janet
Sowden, Sandra
Harvey, John E
Dobson, Lee
Miller, Robert F
Munavvar, Mohammed
Rahman, Najib
Maskell, Nick
author_sort Dipper, Alexandra
collection PubMed
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.
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spelling pubmed-102309802023-06-01 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 Dipper, Alexandra Sundaralingam, Anand Hedley, Emma Tucker, Emma White, Paul Bhatnagar, Rahul Moore, Andrew Dobson, Melissa Luengo-Fernandez, Ramon Mills, Janet Sowden, Sandra Harvey, John E Dobson, Lee Miller, Robert F Munavvar, Mohammed Rahman, Najib Maskell, Nick BMJ Open Respir Res Pleural Disease 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. BMJ Publishing Group 2023-05-30 /pmc/articles/PMC10230980/ /pubmed/37253535 http://dx.doi.org/10.1136/bmjresp-2023-001682 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Pleural Disease
Dipper, Alexandra
Sundaralingam, Anand
Hedley, Emma
Tucker, Emma
White, Paul
Bhatnagar, Rahul
Moore, Andrew
Dobson, Melissa
Luengo-Fernandez, Ramon
Mills, Janet
Sowden, Sandra
Harvey, John E
Dobson, Lee
Miller, Robert F
Munavvar, Mohammed
Rahman, Najib
Maskell, Nick
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 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
topic Pleural Disease
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10230980/
https://www.ncbi.nlm.nih.gov/pubmed/37253535
http://dx.doi.org/10.1136/bmjresp-2023-001682
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