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

Pleural Empyema Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00234208
• Other study ID #: EK 186/05
• Status: Terminated
• Phase: Phase 3
• First received: October 5, 2005
• Last updated: May 23, 2016
• Start date: October 2005
• Est. completion date: January 2007

Study information

• Verified date: May 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complicated Parapneumonic Effusion
• Empyema
• Empyema, Pleural
• Pleural Empyema

Intervention

Procedure:
• Medical thoracoscopy

• Simple chest tube drainage

Locations

Country	Name	City	State
Greece	Department of Pneumology, University Hospital of Alexandroupolis	Alexandroupolis
Italy	Pulmonology Unit, Spedali Civili di Brescia	Brescia
Italy	UO Pneumologia	Imperia
Italy	Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma	Parma
Switzerland	Centre Valaisan de Pneumologie	Crans-Montana

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Lancardis foundation, Martigny Switzerland, Pfizer

Countries where clinical trial is conducted

Greece,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical cure without secondary Intervention			No
Primary	Death			Yes
Secondary	Duration of hospital stay			Yes
Secondary	Radiological outcome			No
Secondary	Duration of drainage			No
Secondary	Total amount of drainage fluid			No
Secondary	Estimated cost			No
Secondary	Adverse events			Yes
Secondary	Pleural pharmacokinetics of linezolid			No