OPEN Research Support
head

Professor
Christian B. Laursen
Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark


Projekt styring
Projekt status    Open
 
Data indsamlingsdatoer
Start 30.03.2022  
Slut 30.03.2027  
 



Intrapleural fibrinolysis and DNase versus video-assisted thoracic surgery (VATS) for the treatment of pleural empyema (FIVERVATS): a national, multicenter, randomised controlled trial

Short summary

Pleural empyema is a frequent disease with a high morbidity and mortality. 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.


Rationale

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.


Description of the cohort

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.


Collaborating researchers and departments

Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark

  • Thomas Decker Christensen
  • Morten Bendixen

Department of Respiratory Medicine, Århus University Hospital

  • Søren Helbo Skaarup

Department of Cardiothoracic Surgery, Odense University Hospital

  • Peter Licht

Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, Copenhagen, Denmark

  • Zaigham Saghir
  • Jens-Ulrik Jensen

Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

  • Rene H. Petersen

Department of Respiratory Medicine & Clinical Institute, Aalborg University Hospital, Aalborg, Denmark

  • Morten H. Borg

Department of Cardiothoracic Surgery, Aalborg University Hospital, Aalborg, Denmark

  • Lars B. Møller

NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK

  • Najib Rahman