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

Lung Cancer Clinical Trial

Official title:

Incidence, Risk Factors and Outcome of Empyema Following Pneumonectomy for Non Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837186
• Other study ID #: EMPY2013
• Status: Completed
• Phase: N/A
• First received: April 15, 2013
• Last updated: April 22, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pneumonectomy for NSCLC

Exclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Belgium	University Hospital Leuven, Dept. Thoracic Surgery	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fast track treatment outcome	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	No
Primary	Overall survival	overall 5-year survival after empyema following pneumonectomy	5 years from surgery	No
Secondary	incidence rate	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	No