Actively Recruiting
VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema
Led by Thomas Decker Christensen · Updated on 2025-10-03
184
Participants Needed
3
Research Sites
313 weeks
Total Duration
On this page
Sponsors
T
Thomas Decker Christensen
Lead Sponsor
O
Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pleura empyema is a frequent disease with a high morbidity and a mortality rate of approximately 15%. Pleura empyema is characterized by the passage of three stages (I - III). The aim of treating the disease is to remove the infection and provide fully expansion of the lung. The initial treatment at the early stage of the disease (stage I) is simple drainage. In clinical practice, stages II and III are treated alike. Current standard treatment for these stages is drainage with ultrasound (ULS) -guided pigtail. Simultaneously with drainage, an intrapleural fibrinolyticum can be given. A potential better alternative is surgery in terms of Video Assisted Thoracoscopic Surgery (VATS). The theoretical advantage of early surgery is that patients undergo rapid, definitive treatment. Furthermore, surgery can ensure optimal drain placement. How best to treat these patients (drainage or surgery) is still under clinical evaluation and depends to a great extent on local clinical practice. It is only to a limited extent based on scientific evidence. The aim of this study is to determine if there is a difference in outcome in patients diagnosed with stage II and stage III empyema who either receive primary VATS surgery or ULS guided drainage and intrapleural therapy (fibrinolytic (altaplasm) with DNase (Pulmozyne ®)) The primary outcome is Hospitalization time and secondary outcomes is e.g. mortality, health related costs and quality of life. The present study can thus provide new and highly relevant knowledge as well as change the treatment of these patients, both nationally and internationally. It is planned that a total of 184 patients will be included in the project. The study takes place as a collaboration between all four thoracic surgical departments and the major pulmonary medicine departments in Denmark. In addition, the study has international collaborators/consultants who will provide counselling in connection with the study.
CONDITIONS
Official Title
VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older on the day of hospitalization
- Ability to provide informed consent
- Acute hospitalization within the last 48 hours
- Clinical signs of pleural infection plus one of the following pleural fluid findings: purulent fluid, positive gram stain or culture, pH below 7.2, low glucose below 2 mmol/L without pH measurement, or septated fluid on ultrasound
You will not qualify if you...
- Pregnancy (fertile women must have a negative pregnancy test before inclusion)
- Breastfeeding
- Terminal illness or expected survival less than 3 months
- Previous intrathoracic surgery on the affected side within the past year
- Hospitalization within the last 7 days prior to current admission
- Previous hospitalization within the past year for complex parapneumonic effusion or pleural empyema
- Drainage during current admission on the affected side (except diagnostic puncture)
- Allergic reaction to alteplase or DNase
- Contraindications to alteplase therapy including current oral anticoagulant use, recent significant bleeding, known bleeding disorders, recent intracranial hemorrhage or brain conditions, recent cardiac resuscitation or trauma, severe uncontrolled hypertension, bacterial endocarditis or pericarditis, acute pancreatitis, recent ulcerative gastrointestinal disease, tumors with bleeding risk, severe liver disease, or recent major surgery or trauma
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Trial Site Locations
Total: 3 locations
1
Aarhus University Hospital
Aarhus, Aarhus, Denmark, 8200
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark
Not Yet Recruiting
3
Odense University Hospital
Odense, Denmark
Actively Recruiting
Research Team
T
Thomas D Christensen, MD, PhD
CONTACT
M
Morten Bendixen, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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