Clinical trial NCT00234208: Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Complicated Parapneumonic Effusion
Pleural Empyema
Keywords: Complicated parapneumonic effusion
Pleural empyema
Intervention
Medical thoracoscopy
Chest tube drainage
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Lancardis Foundation
name: Pfizer
First posted: 2005-10-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Medical cure without secondary Intervention
measure: Death
Secondary outcomes:
measure: Duration of hospital stay
measure: Radiological outcome
measure: Duration of drainage
measure: Total amount of drainage fluid
measure: Estimated cost
measure: Adverse events
measure: Pleural pharmacokinetics of linezolid
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Pneumology, University Hospital of Alexandroupolis
city: Brescia
country: Italy
facility: Pulmonology Unit, Spedali Civili di Brescia
city: Imperia
country: Italy
facility: UO Pneumologia
city: Parma
country: Italy
facility: Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma
city: Crans-Montana
country: Switzerland
facility: Centre Valaisan de Pneumologie
Study officials:
affiliation: Pneumology, Kantonsspital St. Gallen
name: Martin H Brutsche, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: