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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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)

Conditions
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Complicated Parapneumonic Effusion, Pleural Empyema

Intervention / Treatment
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* Procedure: Medical thoracoscopy
* Procedure: Simple chest tube drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septated pleural effusion (ultrasonography) in the context of a lower respiratory tract infection Frank pleural empyema (pus) Exclusion Criteria: Fibrothorax Tuberculous empyema Medical thoracoscopy cannot be performed within 24 hours Pregnancy Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical thoracoscopy<br> | Procedure: Medical thoracoscopy<br> <br> |
| Active Comparator: Simple chest tube drainage<br> | Procedure: Simple chest tube drainage<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical cure without secondary Intervention |  |  | 
| Death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay |  |  | 
| Radiological outcome |  |  | 
| Duration of drainage |  |  | 
| Total amount of drainage fluid |  |  | 
| Estimated cost |  |  | 
| Adverse events |  |  | 
| Pleural pharmacokinetics of linezolid |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complicated parapneumonic effusion, Pleural empyema, Intervention, Medical thoracoscopy, Chest tube drainage