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Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment

INTRODUCTION: Pleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is...

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Autores principales: Christensen, Thomas Decker, Bendixen, Morten, Skaarup, Søren Helbo, Jensen, Jens-Ulrik, Petersen, Rene Horsleben, Christensen, Merete, Licht, Peter, Neckelmann, Kirsten, Bibby, Bo Martin, Møller, Lars B, Bodtger, Uffe, Borg, Morten Hornemann, Saghir, Zaigham, Langfeldt, Sten, Harders, Stefan M W, Bedawi, Eihab O, Naidu, Babu, Rahman, Najib, Laursen, Christian B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8915266/
https://www.ncbi.nlm.nih.gov/pubmed/35264347
http://dx.doi.org/10.1136/bmjopen-2021-054236
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author Christensen, Thomas Decker
Bendixen, Morten
Skaarup, Søren Helbo
Jensen, Jens-Ulrik
Petersen, Rene Horsleben
Christensen, Merete
Licht, Peter
Neckelmann, Kirsten
Bibby, Bo Martin
Møller, Lars B
Bodtger, Uffe
Borg, Morten Hornemann
Saghir, Zaigham
Langfeldt, Sten
Harders, Stefan M W
Bedawi, Eihab O
Naidu, Babu
Rahman, Najib
Laursen, Christian B
author_facet Christensen, Thomas Decker
Bendixen, Morten
Skaarup, Søren Helbo
Jensen, Jens-Ulrik
Petersen, Rene Horsleben
Christensen, Merete
Licht, Peter
Neckelmann, Kirsten
Bibby, Bo Martin
Møller, Lars B
Bodtger, Uffe
Borg, Morten Hornemann
Saghir, Zaigham
Langfeldt, Sten
Harders, Stefan M W
Bedawi, Eihab O
Naidu, Babu
Rahman, Najib
Laursen, Christian B
author_sort Christensen, Thomas Decker
collection PubMed
description INTRODUCTION: Pleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of video-assisted thoracoscopic surgery (VATS) as first-line treatment. The aim of this study is to determine the difference in outcome in patients diagnosed with complex parapneumonic effusion (stage II) and pleural empyema (stage III) who are treated with either VATS surgery or TUS-guided drainage and intrapleural therapy (fibrinolytic (Alteplase) with DNase (Pulmozyme)) as first-line treatment. METHODS AND ANALYSIS: A national, multicentre randomised, controlled study. Totally, 184 patients with a newly diagnosed community acquired complicated parapneumonic effusion or pleural empyema are randomised to either (1) VATS procedure with drainage or (2) TUS-guided pigtail catheter placement and intrapleural therapy with Actilyse and DNase. The total follow-up period is 12 months. The primary endpoint is length of hospital stay and secondary endpoints include for example, mortality, need for additional interventions, consumption of analgesia and quality of life. ETHICS AND DISSEMINATION: All patients provide informed consent before randomisation. The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. Information about the subjects is protected under the Personal Data Processing Act and the Health Act. The trial is registered at www.clinicaltrials.gov, and monitored by the regional Good clinical practice monitoring unit. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences. TRIAL REGISTRATION NUMBER: NCT04095676.
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spelling pubmed-89152662022-03-25 Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment Christensen, Thomas Decker Bendixen, Morten Skaarup, Søren Helbo Jensen, Jens-Ulrik Petersen, Rene Horsleben Christensen, Merete Licht, Peter Neckelmann, Kirsten Bibby, Bo Martin Møller, Lars B Bodtger, Uffe Borg, Morten Hornemann Saghir, Zaigham Langfeldt, Sten Harders, Stefan M W Bedawi, Eihab O Naidu, Babu Rahman, Najib Laursen, Christian B BMJ Open Respiratory Medicine INTRODUCTION: Pleural empyema is a frequent disease with a high morbidity and mortality. Current standard treatment includes antibiotics and thoracic ultrasound (TUS)-guided pigtail drainage. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of video-assisted thoracoscopic surgery (VATS) as first-line treatment. The aim of this study is to determine the difference in outcome in patients diagnosed with complex parapneumonic effusion (stage II) and pleural empyema (stage III) who are treated with either VATS surgery or TUS-guided drainage and intrapleural therapy (fibrinolytic (Alteplase) with DNase (Pulmozyme)) as first-line treatment. METHODS AND ANALYSIS: A national, multicentre randomised, controlled study. Totally, 184 patients with a newly diagnosed community acquired complicated parapneumonic effusion or pleural empyema are randomised to either (1) VATS procedure with drainage or (2) TUS-guided pigtail catheter placement and intrapleural therapy with Actilyse and DNase. The total follow-up period is 12 months. The primary endpoint is length of hospital stay and secondary endpoints include for example, mortality, need for additional interventions, consumption of analgesia and quality of life. ETHICS AND DISSEMINATION: All patients provide informed consent before randomisation. The research project is carried out in accordance with the Helsinki II Declaration, European regulations and Good Clinical Practice Guidelines. The Scientific Ethics Committees for Denmark and the Danish Data Protection Agency have provided permission. Information about the subjects is protected under the Personal Data Processing Act and the Health Act. The trial is registered at www.clinicaltrials.gov, and monitored by the regional Good clinical practice monitoring unit. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences. TRIAL REGISTRATION NUMBER: NCT04095676. BMJ Publishing Group 2022-03-08 /pmc/articles/PMC8915266/ /pubmed/35264347 http://dx.doi.org/10.1136/bmjopen-2021-054236 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Respiratory Medicine
Christensen, Thomas Decker
Bendixen, Morten
Skaarup, Søren Helbo
Jensen, Jens-Ulrik
Petersen, Rene Horsleben
Christensen, Merete
Licht, Peter
Neckelmann, Kirsten
Bibby, Bo Martin
Møller, Lars B
Bodtger, Uffe
Borg, Morten Hornemann
Saghir, Zaigham
Langfeldt, Sten
Harders, Stefan M W
Bedawi, Eihab O
Naidu, Babu
Rahman, Najib
Laursen, Christian B
Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment
title Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment
title_full Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment
title_fullStr Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment
title_full_unstemmed Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment
title_short Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): protocol for a randomised, controlled trial – surgery as first-line treatment
title_sort intrapleural fibrinolysis and dnase versus video-assisted thoracic surgery (vats) for the treatment of pleural empyema (fivervats): protocol for a randomised, controlled trial – surgery as first-line treatment
topic Respiratory Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8915266/
https://www.ncbi.nlm.nih.gov/pubmed/35264347
http://dx.doi.org/10.1136/bmjopen-2021-054236
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