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
  Purpose

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 Intervention Phase
Complicated Parapneumonic Effusion
Pleural Empyema
Procedure: Medical thoracoscopy
Procedure: Simple chest tube drainage
Phase 3

Study Type: Interventional
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)

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Medical cure without secondary Intervention
  • Death

Secondary Outcome Measures:
  • Duration of hospital stay
  • Radiological outcome
  • Duration of drainage
  • Total amount of drainage fluid
  • Estimated cost
  • Adverse events
  • Pleural pharmacokinetics of linezolid

Estimated Enrollment: 100
Study Start Date: October 2005
Estimated Study Completion Date: October 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234208

Contacts
Contact: Martin A Brutsche, MD, PhD +41612655194 mbrutsche@uhbs.ch
Contact: Jan A Wiegand, MD wiegandj@uhbs.ch

Locations
Greece
Department of Pneumology, University Hospital of Alexandroupolis Recruiting
Alexandroupolis, Greece, 68100
Contact: Marios E Froudarakis, MD, PhD       froudarm@uoc.gr   
Principal Investigator: Marios E Froudarakis, MD, PhD         
Italy
Pulmonology Unit, Spedali Civili di Brescia Recruiting
Brescia, Italy, 25103
Contact: Gian F Tassi, MD    +39 030 3995591    g.f.tassi@spedalicivili.brescia.it   
Principal Investigator: Gian F Tassi, MD         
UO Pneumologia Recruiting
Imperia, Italy, 18100
Contact: Marco Nosenzo, MD       m.nosenzo@asl1.liguria.it   
Principal Investigator: Marco Nosenzo, MD         
Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma Recruiting
Parma, Italy, 43100
Contact: Angelo G Casalini, MD    +39 0521 703416    angelocasalini@inwind.it   
Principal Investigator: Angelo G Casalini, MD         
Switzerland
University Hospital Recruiting
Basel, Switzerland, CH-4031
Contact: Martin H Brutsche, MD, PhD    +41612655194    mbrutsche@uhbs.ch   
Contact: Jan A Wiegand, MD       wiegandj@uhbs.ch   
Sub-Investigator: Jan A Wiegand, MD         
Principal Investigator: Martin H Brutsche, MD, PhD         
Centre Valaisan de Pneumologie Not yet recruiting
Crans-Montana, Switzerland, CH-3963
Contact: Jean-Marie Tschopp, MD    + 41 27 603 81 80    jean-marie.tschopp@admin.vs.ch   
Principal Investigator: Jean-Marie Tschopp, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Lancardis foundation, Martigny Switzerland
Pfizer
Investigators
Principal Investigator: Martin H Brutsche, MD, PhD Pneumology, University Hospital of Basel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234208     History of Changes
Other Study ID Numbers: EK 186/05
Study First Received: October 5, 2005
Last Updated: April 24, 2007
Health Authority: Switzerland: Laws and standards

Keywords provided by University Hospital, Basel, Switzerland:
Complicated parapneumonic effusion
Pleural empyema
Intervention
Medical thoracoscopy
Chest tube drainage

Additional relevant MeSH terms:
Empyema
Empyema, Pleural
Suppuration
Infection
Inflammation
Pathologic Processes
Respiratory Tract Infections
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014