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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234208
Recruitment Status : Terminated (insufficient enrollment)
First Posted : October 6, 2005
Last Update Posted : May 24, 2016
Lancardis Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Complicated Parapneumonic Effusion Pleural Empyema Procedure: Medical thoracoscopy Procedure: Simple chest tube drainage Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : October 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Arm Intervention/treatment
Experimental: Medical thoracoscopy Procedure: Medical thoracoscopy
Active Comparator: Simple chest tube drainage Procedure: Simple chest tube drainage

Primary Outcome Measures :
  1. Medical cure without secondary Intervention
  2. Death

Secondary Outcome Measures :
  1. Duration of hospital stay
  2. Radiological outcome
  3. Duration of drainage
  4. Total amount of drainage fluid
  5. Estimated cost
  6. Adverse events
  7. Pleural pharmacokinetics of linezolid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234208

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Department of Pneumology, University Hospital of Alexandroupolis
Alexandroupolis, Greece, 68100
Pulmonology Unit, Spedali Civili di Brescia
Brescia, Italy, 25103
UO Pneumologia
Imperia, Italy, 18100
Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma
Parma, Italy, 43100
Centre Valaisan de Pneumologie
Crans-Montana, Switzerland, CH-3963
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Lancardis Foundation
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Principal Investigator: Martin H Brutsche, MD, Prof. Pneumology, Kantonsspital St. Gallen
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Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00234208    
Other Study ID Numbers: EK 186/05
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016
Keywords provided by University Hospital, Basel, Switzerland:
Complicated parapneumonic effusion
Pleural empyema
Medical thoracoscopy
Chest tube drainage
Additional relevant MeSH terms:
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Empyema, Pleural
Pathologic Processes
Respiratory Tract Infections
Pleural Diseases
Respiratory Tract Diseases