Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234208
Status:
TERMINATED
Last Update Posted:
2016-05-24
First Post:
2005-10-05
Brief Title:
Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None