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

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ClinicalTrials.gov Identifier: NCT01837186
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
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.

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
U.S. FDA Resources

Group/Cohort
EFP
Empyema following pneumonectomy
nEFP
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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01837186


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

Responsible Party: Johnny Moons, Datamanager Thoracic Surgery, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01837186     History of Changes
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:
Surgery
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Empyema
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Suppuration
Infection
Inflammation
Pathologic Processes