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

Condition(s) targeted: Complicated Parapneumonic Effusion; Pleural Empyema

Intervention: Medical thoracoscopy (Procedure); Simple chest tube drainage (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospital, Basel, Switzerland

Official(s) and/or principal investigator(s):
Martin H Brutsche, MD, PhD, Principal Investigator, Affiliation: Pneumology, University Hospital of Basel

Overall contact:
Martin A Brutsche, MD, PhD, Phone: +41612655194, Email: mbrutsche@uhbs.ch

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

Medical cure without secondary Intervention

Death

Secondary outcome:

Duration of hospital stay

Radiological outcome

Duration of drainage

Total amount of drainage fluid

Estimated cost

Adverse events

Pleural pharmacokinetics of linezolid

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Martin A Brutsche, MD, PhD, Phone: +41612655194, Email: mbrutsche@uhbs.ch

Department of Pneumology, University Hospital of Alexandroupolis, Alexandroupolis 68100, Greece; Recruiting
Marios E Froudarakis, MD, PhD, Email: froudarm@uoc.gr
Marios E Froudarakis, MD, PhD, Principal Investigator

Pulmonology Unit, Spedali Civili di Brescia, Brescia 25103, Italy; Recruiting
Gian F Tassi, MD, Phone: +39 030 3995591, Email: g.f.tassi@spedalicivili.brescia.it
Gian F Tassi, MD, Principal Investigator

Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma, Parma 43100, Italy; Recruiting
Angelo G Casalini, MD, Phone: +39 0521 703416, Email: angelocasalini@inwind.it
Angelo G Casalini, MD, Principal Investigator

UO Pneumologia, Imperia 18100, Italy; Recruiting
Marco Nosenzo, MD, Email: m.nosenzo@asl1.liguria.it
Marco Nosenzo, MD, Principal Investigator

University Hospital, Basel CH-4031, Switzerland; Recruiting
Martin H Brutsche, MD, PhD, Phone: +41612655194, Email: mbrutsche@uhbs.ch
Jan A Wiegand, MD, Email: wiegandj@uhbs.ch
Jan A Wiegand, MD, Sub-Investigator
Martin H Brutsche, MD, PhD, Principal Investigator

Centre Valaisan de Pneumologie, Crans-Montana CH-3963, Switzerland; Not yet recruiting
Jean-Marie Tschopp, MD, Phone: + 41 27 603 81 80, Email: jean-marie.tschopp@admin.vs.ch
Jean-Marie Tschopp, MD, Principal Investigator

Starting date: October 2005
Ending date: October 2008
Last updated: April 24, 2007