- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01837186
Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)
April 22, 2013 updated by: Johnny Moons, University Hospital, Gasthuisberg
Incidence, Risk Factors and Outcome of Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)
Empyema following pneumonectomy for Non Small Cell Lung Cancer (NSCLC) is a known problem that occurs in about 2% of pneumonectomy patients.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leuven, Belgium, 3000
- University Hospital Leuven, Dept. Thoracic Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
Inclusion Criteria:
- Pneumonectomy for NSCLC
Exclusion Criteria:
- Pneumonectomy for other reasons (infectious pathology, trauma, mesothelioma, ...)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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EFP
Empyema following pneumonectomy
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nEFP
No empyema following pneumonectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 5 years from surgery
|
overall 5-year survival after empyema following pneumonectomy
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5 years from surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence rate
Time Frame: 1 and 5 years from surgery
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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.
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1 and 5 years from surgery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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5 years from surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Paul De Leyn, PhD; MD, UZ Leuven, Dept. Thoracic Surgery
- Principal Investigator: Arnaud Colle, University Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
April 15, 2013
First Submitted That Met QC Criteria
April 22, 2013
First Posted (Estimate)
April 23, 2013
Study Record Updates
Last Update Posted (Estimate)
April 23, 2013
Last Update Submitted That Met QC Criteria
April 22, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMPY2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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