A Phase 3 interventional study of Medical thoracoscopy and Simple chest tube drainage in Complicated Parapneumonic Effusion and Pleural Empyema, sponsored by University Hospital, Basel, Switzerland. Terminated at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-24.
Sponsored by University Hospital, Basel, Switzerland · Phase 3, Interventional, and Treatment
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.
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.
33 studies on the registry are indexed under Empyema, Pleural; 11 are open to participants now.
This study's enrollment of 2 is below the median of 77 across 26 interventional studies indexed under Empyema, Pleural.
Browse Empyema, Pleural studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Medical thoracoscopy
Procedure: Simple chest tube drainage
Medical cure without secondary Intervention
Death
Duration of hospital stay
Radiological outcome
Duration of drainage
Total amount of drainage fluid
Estimated cost
Adverse events
Pleural pharmacokinetics of linezolid
This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →