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

This study has been terminated.
(insufficient enrollment)
Sponsor:
Collaborators:
Lancardis foundation, Martigny Switzerland
Pfizer
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00234208
First received: October 5, 2005
Last updated: May 23, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Complicated Parapneumonic Effusion
Pleural Empyema
Procedure: Medical thoracoscopy
Procedure: Simple chest tube drainage
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Medical cure without secondary Intervention [ Designated as safety issue: No ]
  • Death [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of hospital stay [ Designated as safety issue: Yes ]
  • Radiological outcome [ Designated as safety issue: No ]
  • Duration of drainage [ Designated as safety issue: No ]
  • Total amount of drainage fluid [ Designated as safety issue: No ]
  • Estimated cost [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Pleural pharmacokinetics of linezolid [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medical thoracoscopy Procedure: Medical thoracoscopy
Active Comparator: Simple chest tube drainage Procedure: Simple chest tube drainage

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234208

Locations
Greece
Department of Pneumology, University Hospital of Alexandroupolis
Alexandroupolis, Greece, 68100
Italy
Pulmonology Unit, Spedali Civili di Brescia
Brescia, Italy, 25103
UO Pneumologia
Imperia, Italy, 18100
Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma
Parma, Italy, 43100
Switzerland
Centre Valaisan de Pneumologie
Crans-Montana, Switzerland, CH-3963
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Lancardis foundation, Martigny Switzerland
Pfizer
Investigators
Principal Investigator: Martin H Brutsche, MD, Prof. Pneumology, Kantonsspital St. Gallen
  More Information

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00234208     History of Changes
Other Study ID Numbers: EK 186/05 
Study First Received: October 5, 2005
Last Updated: May 23, 2016
Health Authority: Switzerland: Laws and standards

Keywords provided by University Hospital, Basel, Switzerland:
Complicated parapneumonic effusion
Pleural empyema
Intervention
Medical thoracoscopy
Chest tube drainage

Additional relevant MeSH terms:
Empyema
Empyema, Pleural
Suppuration
Infection
Inflammation
Pathologic Processes
Respiratory Tract Infections
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 25, 2016