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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by University Hospital, Basel, Switzerland.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Lancardis foundation, Martigny Switzerland
Pfizer
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00234208
First received: October 5, 2005
Last updated: April 24, 2007
Last verified: October 2005

October 5, 2005
April 24, 2007
October 2005
Not Provided
  • Medical cure without secondary Intervention
  • Death
Same as current
Complete list of historical versions of study NCT00234208 on ClinicalTrials.gov Archive Site
  • Duration of hospital stay
  • Radiological outcome
  • Duration of drainage
  • Total amount of drainage fluid
  • Estimated cost
  • Adverse events
  • Pleural pharmacokinetics of linezolid
  • Duration of hospital stay
  • Estimated cost
  • Adverse events
  • Pleural pharmacokinetics of linezolid
Not Provided
Not Provided
 
Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Complicated Parapneumonic Effusion
  • Pleural Empyema
  • Procedure: Medical thoracoscopy
  • Procedure: Simple chest tube drainage
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
October 2008
Not Provided

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
Both
18 Years and older
No
Contact: Martin A Brutsche, MD, PhD +41612655194 mbrutsche@uhbs.ch
Contact: Jan A Wiegand, MD wiegandj@uhbs.ch
Greece,   Italy,   Switzerland
 
NCT00234208
EK 186/05
Not Provided
Not Provided
University Hospital, Basel, Switzerland
  • Lancardis foundation, Martigny Switzerland
  • Pfizer
Principal Investigator: Martin H Brutsche, MD, PhD Pneumology, University Hospital of Basel
University Hospital, Basel, Switzerland
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP