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
Najib Rahman,
Babu Naidu,
Eihab O Bedawi,
Zaigham Saghir,
Uffe Bodtger,
Bo Martin Bibby,
Christian B Laursen,
Thomas Decker Christensen,
Morten Bendixen,
Søren Helbo Skaarup,
Jens-Ulrik Jensen,
Rene Horsleben Petersen,
Merete Christensen,
Peter Licht,
Kirsten Neckelmann,
Lars B Møller,
Morten Hornemann Borg,
Sten Langfeldt,
Stefan M W Harders
Affiliations
Najib Rahman
Oxford NIHR Biomedical Research Centre, Oxford, UK
Babu Naidu
Department of Thoracic Surgery, University Hospitals Birmingham, Birmingham, UK
Eihab O Bedawi
NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK
Zaigham Saghir
Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, Copenhagen, Denmark
Uffe Bodtger
Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark
Bo Martin Bibby
7 Department of Biostatistics, Aarhus University, Aarhus, Denmark
Christian B Laursen
Odense Respiratory Research Unit (ODIN), Department of Clinical Research, University of Southern Denmark, Odense, Denmark
Thomas Decker Christensen
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
Morten Bendixen
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
Søren Helbo Skaarup
Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark
Jens-Ulrik Jensen
Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, Copenhagen, Denmark
Rene Horsleben Petersen
Department of Cardiothoracic Surgery, Copenhagen University Hospital Rigshospitalet, København, Denmark
Merete Christensen
Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Peter Licht
Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark
Kirsten Neckelmann
Department of Cardiothoracic Surgery, Odense University Hospital, Odense, Denmark
Lars B Møller
Department of Cardiothoracic Surgery, Aalborg University Hospital, Aalborg, Denmark
Morten Hornemann Borg
Department of Respiratory Medicine & Clinical Institute, Aalborg University Hospital, Aalborg, Denmark
Sten Langfeldt
Department of Radiology, Aarhus University Hospital, Aarhus, Denmark
Stefan M W Harders
Department of Radiology, Odense University Hospital, Odense, Denmark
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.
