Pleural Empyema Clinical Trial
Official title:
A Randomized Controlled Study of Early Mini-invasive Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusions or Pleural Empyema - ESMITE (European Study on Mini-invasive Thoracoscopy in Empyema)
Multicenter, randomized controlled study to compare early mini-invasive thoracoscopy to simple chest tube drainage in complicated parapneumonic effusions or pleural empyema. 100 patients will be recruited. Follow-up will be 3 months. It will be looked at the rate medical cure, the need for secondary interventions, death and duration of hospital stay. In a nested trial in 20 patients the intrapleural pharmacokinetics of linezolid (approved antibiotic agent) will be measured.
Background Pleural empyema has a high morbidity and mortality. Until now it is not clear
which method is best to initially drain the pus, especially in complicated effusions with
septa.
The objective of this study is to compare the standard treatment of simple chest tube
drainage to early mini-invasive medical thoracoscopy. In earlier studies medical
thoracoscopy has been a safe and effective method in pleural diseases. However there is no
prospective data available.
Methods We conduct a prospective randomized controlled multicenter study on 100 patients
with complicated parapneumonic effusions with septa or empyema with frank pus. Patients will
be randomized to receive either simple chest tube drainage or early medical thoracoscopy.
The latter will be performed in local anaesthesia and analgosedation according to the
standards set by the European Study on Medical Video-Assisted Thoracoscopy (ESMEVAT)-group.
Fibrinolysis will be used routinely. In 20 patients a nested study on the intrapleural
pharmacokinetics of linezolid as antibiotic agent will be performed.
Follow-up will be structured on day 1, day 7, before discharge and after 3 months including
chest radiographs and clinical and laboratory evaluations.
Outcome Primary outcome will be medical cure without the need of secondary intervention or
death.
As secondary outcome we will measure duration of hospital stay, adverse events.
Provisional agenda Start of study: October 2005 End of study: October 2007
Potential outcome & benefit The study should clarify the role of early medical thoracoscopy
in patients with complicated parapneumonic effusions or pleural empyema. Different authors
have speculated that early intervention could be preferable. On the other hand, in many
centres worldwide patients are primarily treated by a simple chest tube with or without
pleural fibrinolysis. In case of failure of simple drainage, but this means several
"precious" days later, a more invasive procedure is needed. At that moment tight pleural
septa have formed, and often a surgical VATS or thoracotomy in general anaesthesia becomes
necessary. Therefore, this pivotal study could lead to changes in the management of patients
with pleural empyema.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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