ClinicalTrials.Veeva

Menu

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

University Hospital Basel logo

University Hospital Basel

Status and phase

Terminated
Phase 3

Conditions

Complicated Parapneumonic Effusion
Pleural Empyema

Treatments

Procedure: Simple chest tube drainage
Procedure: Medical thoracoscopy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00234208
EK 186/05

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Medical thoracoscopy
Experimental group
Treatment:
Procedure: Medical thoracoscopy
Simple chest tube drainage
Active Comparator group
Treatment:
Procedure: Simple chest tube drainage

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems