Fibrinolytic Therapy Versus Medical Thoracoscopy

Pleural infection (empyema or complex parapneumonic effusion [CPPE]) represents one of the
common clinical diagnoses encountered in clinical practice in the United States (US) and
worldwide. The incidence of pleural infection continues to rise with an annual incidence of
approximately 65,000 in the US and United Kingdom (UK). It is associated with substantial
morbidity and mortality as well as increased hospital costs despite advances in medical
diagnostic and therapeutic strategies. The overall mortality of pleural infection approaches
20% and it is above 30% in elderly patients over 65 years and immunocompromised patients.

Treatment of CPPE or empyema requires antibiotics and drainage of the pleural cavity.3
However, in about 30% of cases, it is difficult to remove the fluid due to loculations,
septations and increased viscosity of the pleural fluid, and around 20% will need surgical
intervention to adequately treat the pleural infection.

Specific Aim 1:

To compare the efficacy of early medical thoracoscopy versus fibrinolytic therapy (tPA/DNase)
in patients with complicated parapneumonic effusions or pleural empyema.

CPPE is defined as non-purulent effusion in a patient with clinical evidence of infection
such as fever and/or elevated blood leukocyte count and/or elevated CRP, with pleural fluid
pH ≤ 7.2 (measured by blood-gas analyzer), or pleural fluid glucose < 60 mg/dl or pleural
fluid LDH >1000 IU/L26. Empyema is defined as pus within the pleural space and/or presence of
bacteria on pleural fluid Gram stain or culture.

For patients to be considered for the trial they need to fulfill one of the following
criteria: 1) CPPE along with evidence of septated pleural effusion on pleural ultrasonography
and/or chest CT scan or 2) empyema.

Inclusion Criteria:

1. CPPE along with evidence of septated pleural effusion on pleural ultrasonography
and/or chest CT scan

2. empyema.

Exclusion Criteria:

1. age <18 years;

2. Pregnancy

3. inability to give informed written consent;

4. previous thoracic surgery or thrombolytic therapy for pleural infection;

5. medical thoracoscopy cannot be performed within 48 hours;

6. inability to tolerate procedure due to hemodynamic instability or severe hypoxemia;

7. inability to correct coagulopathy;

8. presence of a homogeneously echogenic effusion on pleural US27 -