Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved]
Background: Malignant pleural effusion (MPE) is the build-up of pleural fluid in the space between the lung and chest wall due to advanced cancer. It is treated initially by large volume drainage (therapeutic aspiration). If the fluid reaccumulates, a definitive procedure is performed. There is wide...
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2023-01-01
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| Series: | NIHR Open Research |
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| Online Access: | https://openresearch.nihr.ac.uk/articles/3-5/v1 |
| _version_ | 1797681973821440000 |
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| author | Eleanor K. Mishra Magda Laskawiec-Szkonter Allan Clark Najib M. Rahman Nicholas A. Maskell |
| author_facet | Eleanor K. Mishra Magda Laskawiec-Szkonter Allan Clark Najib M. Rahman Nicholas A. Maskell |
| author_sort | Eleanor K. Mishra |
| collection | DOAJ |
| description | Background: Malignant pleural effusion (MPE) is the build-up of pleural fluid in the space between the lung and chest wall due to advanced cancer. It is treated initially by large volume drainage (therapeutic aspiration). If the fluid reaccumulates, a definitive procedure is performed. There is wide variation in rate of reaccumulation. Patients with rapid reaccumulation often attend hospital as an emergency. Conversely, patients with slow reaccumulation do not need a definitive procedure and may experience cancelled or unnecessary procedures. This study aims to create and validate a multivariable prediction model to predict how quickly pleural fluid will reaccumulate in patients with MPE following therapeutic aspiration. Research question: Can we predict how quickly pleural fluid will reaccumulate in patients with MPEs? Methods: A total of 200 patients with known or suspected MPE attending for therapeutic aspiration will be recruited from 5-10 UK hospitals over 20 months. Patients will be enrolled prior to undergoing aspiration. Following this, they will undergo chest X-ray, which will be repeated one week later (treatment as usual). Rate of reaccumulation will be calculated based on change of size of the effusion seen on X-ray. Data will be collected on common clinical biomarkers e.g., size of effusion on pre-aspiration chest X-ray, volume of fluid drained. This data will be analysed to create a clinical score. A further validation cohort of 40 patients will be enrolled in parallel with creation of the score. Anticipated impact: The ability to predict rate of reaccumulation of MPE will enable patients and clinicians to make better informed treatment decisions. For patients with predicted rapid reaccumulation, a definitive procedure could be offered as first-line treatment, rather than a therapeutic aspiration. This will prevent emergency hospital admissions and decrease number of procedures. By contrast, patients whose effusions will recur slowly may avoid an unnecessary procedure. |
| first_indexed | 2024-03-11T23:52:47Z |
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| institution | Directory Open Access Journal |
| issn | 2633-4402 |
| language | English |
| last_indexed | 2024-03-11T23:52:47Z |
| publishDate | 2023-01-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | NIHR Open Research |
| spelling | doaj.art-16b1db8eb3364e899c6fd56f35dfc5e22023-09-19T00:00:00ZengF1000 Research LtdNIHR Open Research2633-44022023-01-01314402Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved]Eleanor K. Mishra0https://orcid.org/0000-0002-5903-3005Magda Laskawiec-Szkonter1Allan Clark2Najib M. Rahman3Nicholas A. Maskell4University of East Anglia, Norwich, NR4 7TL, UKOxford Respiratory Trials Unit, University of Oxford, Oxford, OX3 7LE, UKUniversity of East Anglia, Norwich, NR4 7TL, UKOxford Respiratory Trials Unit, University of Oxford, Oxford, OX3 7LE, UKUniversity of Bristol, Bristol, BS8 1TH, UKBackground: Malignant pleural effusion (MPE) is the build-up of pleural fluid in the space between the lung and chest wall due to advanced cancer. It is treated initially by large volume drainage (therapeutic aspiration). If the fluid reaccumulates, a definitive procedure is performed. There is wide variation in rate of reaccumulation. Patients with rapid reaccumulation often attend hospital as an emergency. Conversely, patients with slow reaccumulation do not need a definitive procedure and may experience cancelled or unnecessary procedures. This study aims to create and validate a multivariable prediction model to predict how quickly pleural fluid will reaccumulate in patients with MPE following therapeutic aspiration. Research question: Can we predict how quickly pleural fluid will reaccumulate in patients with MPEs? Methods: A total of 200 patients with known or suspected MPE attending for therapeutic aspiration will be recruited from 5-10 UK hospitals over 20 months. Patients will be enrolled prior to undergoing aspiration. Following this, they will undergo chest X-ray, which will be repeated one week later (treatment as usual). Rate of reaccumulation will be calculated based on change of size of the effusion seen on X-ray. Data will be collected on common clinical biomarkers e.g., size of effusion on pre-aspiration chest X-ray, volume of fluid drained. This data will be analysed to create a clinical score. A further validation cohort of 40 patients will be enrolled in parallel with creation of the score. Anticipated impact: The ability to predict rate of reaccumulation of MPE will enable patients and clinicians to make better informed treatment decisions. For patients with predicted rapid reaccumulation, a definitive procedure could be offered as first-line treatment, rather than a therapeutic aspiration. This will prevent emergency hospital admissions and decrease number of procedures. By contrast, patients whose effusions will recur slowly may avoid an unnecessary procedure.https://openresearch.nihr.ac.uk/articles/3-5/v1Pleural effusion cancer therapeutic aspiration breathlessnesseng |
| spellingShingle | Eleanor K. Mishra Magda Laskawiec-Szkonter Allan Clark Najib M. Rahman Nicholas A. Maskell Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved] NIHR Open Research Pleural effusion cancer therapeutic aspiration breathlessness eng |
| title | Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved] |
| title_full | Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved] |
| title_fullStr | Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved] |
| title_full_unstemmed | Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved] |
| title_short | Trial Protocol: Reaccumulation rate of pleural effusions after therapeutic aspiration: An observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic (REPEAT) [version 1; peer review: 2 approved] |
| title_sort | trial protocol reaccumulation rate of pleural effusions after therapeutic aspiration an observational cohort study to determine baseline factors associated with rate of pleural fluid reaccumulation following therapeutic aspiration in patients with malignant pleural effusion attending a pleural clinic repeat version 1 peer review 2 approved |
| topic | Pleural effusion cancer therapeutic aspiration breathlessness eng |
| url | https://openresearch.nihr.ac.uk/articles/3-5/v1 |
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