Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema
Complicated Parapneumonic Effusion
Procedure: Medical thoracoscopy
Procedure: Simple chest tube drainage
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Medical cure without secondary Intervention [ Designated as safety issue: No ]
- Death [ Designated as safety issue: Yes ]
- Duration of hospital stay [ Designated as safety issue: Yes ]
- Radiological outcome [ Designated as safety issue: No ]
- Duration of drainage [ Designated as safety issue: No ]
- Total amount of drainage fluid [ Designated as safety issue: No ]
- Estimated cost [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
- Pleural pharmacokinetics of linezolid [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
|Experimental: Medical thoracoscopy||Procedure: Medical thoracoscopy|
|Active Comparator: Simple chest tube drainage||Procedure: Simple chest tube drainage|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234208
|Department of Pneumology, University Hospital of Alexandroupolis|
|Alexandroupolis, Greece, 68100|
|Pulmonology Unit, Spedali Civili di Brescia|
|Brescia, Italy, 25103|
|Imperia, Italy, 18100|
|Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma|
|Parma, Italy, 43100|
|Centre Valaisan de Pneumologie|
|Crans-Montana, Switzerland, CH-3963|
|Principal Investigator:||Martin H Brutsche, MD, Prof.||Pneumology, Kantonsspital St. Gallen|