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

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven, Dept. Thoracic Surgery

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
EFP
Empyema following pneumonectomy
nEFP
No empyema following pneumonectomy

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
5 years from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 and 5 years from surgery

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.
5 years from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

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

Keywords

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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