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Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01837186
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):
Johnny Moons, University Hospital, Gasthuisberg

Brief Summary:
Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem that occurs in about 2% of pneumonectomy patients.

Condition or disease
Non Small Cell Lung Cancer Lung Cancer

Detailed Description:
The development of an empyema following pneumonectomy is a devastating complication, especially if associated with an underlying fistula. Whilst the perioperative mortality of pneumonectomy overall is now less than 5%, this rises to around 25% when complicated by empyema, and about 50% when associated with fistula. In addition, there is the morbidity and social cost of long-term drainage, chronic sepsis and often multiple operations.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence, Risk Factors and Outcome of Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)
Study Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Empyema following pneumonectomy
No empyema following pneumonectomy

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years from surgery ]
    overall 5-year survival after empyema following pneumonectomy

Secondary Outcome Measures :
  1. incidence rate [ Time Frame: 1 and 5 years from surgery ]
    incidence of empyema, accompanied with broncho-pleural fistula or not, divided in short term (less than 1 yr postoperatively) and long term (up to 5 years postoperatively) incidence.

Other Outcome Measures:
  1. fast track treatment outcome [ Time Frame: 5 years from surgery ]
    over the last 7 years, a new approach - known as 'fast track treatment of Empyema following pneumonectomy (EFP)' is used. We will examine if there is a benificial aspect in this approach, regarding survival en hospital stay.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive pneumonectomies for Non Small Cell Lung Cancer (NSCLC) from the University Hospital Leuven from 1996 till 2012

Inclusion Criteria:

  • Pneumonectomy for NSCLC

Exclusion Criteria:

  • Pneumonectomy for other reasons (infectious pathology, trauma, mesothelioma, ...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01837186

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University Hospital Leuven, Dept. Thoracic Surgery
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
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Study Director: Paul De Leyn, PhD; MD UZ Leuven, Dept. Thoracic Surgery
Principal Investigator: Arnaud Colle University Leuven

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Responsible Party: Johnny Moons, Datamanager Thoracic Surgery, University Hospital, Gasthuisberg Identifier: NCT01837186    
Other Study ID Numbers: EMPY2013
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by Johnny Moons, University Hospital, Gasthuisberg:
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pathologic Processes