Clinical Trial: Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Controlled Study of Early Mini-invasive Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusions or Pleural Empyema - ESM

Brief Summary: 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.

Detailed Summary:

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 complicat
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome:

  • Medical cure without secondary Intervention
  • Death


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of hospital stay
  • Radiological outcome
  • Duration of drainage
  • Total amount of drainage fluid
  • Estimated cost
  • Adverse events
  • Pleural pharmacokinetics of linezolid


Original Secondary Outcome:

  • Duration of hospital stay
  • Estimated cost
  • Adverse events
  • Pleural pharmacokinetics of linezolid


Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: October 5, 2005
Date Started: October 2005
Date Completion:
Last Updated: May 23, 2016
Last Verified: May 2016