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

NCT ID: NCT00234208

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2007-01-31

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.

Conditions

Complicated Parapneumonic Effusion; Pleural Empyema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medical thoracoscopy

Group Type: EXPERIMENTAL

Medical thoracoscopy

Intervention Type: PROCEDURE

Simple chest tube drainage

Group Type: ACTIVE_COMPARATOR

Simple chest tube drainage

Intervention Type: PROCEDURE

Interventions

Medical thoracoscopy

Intervention Type: PROCEDURE

Simple chest tube drainage

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lancardis Foundation

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin H Brutsche, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Pneumology, Kantonsspital St. Gallen

Locations

Department of Pneumology, University Hospital of Alexandroupolis

Alexandroupoli, , Greece

Pulmonology Unit, Spedali Civili di Brescia

Brescia, , Italy

UO Pneumologia

Imperia, , Italy

Pulmonology and Thoracic Endoscopy Unit Azienda Ospedaliera di Parma

Parma, , Italy

Centre Valaisan de Pneumologie

Crans-Montana, , Switzerland

Countries

Greece; Italy; Switzerland

Other Identifiers

EK 186/05

Identifier Type: -

Identifier Source: org_study_id