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Completed

NCT Number: NCT01837186

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Leuven, Dept. Thoracic Surgery

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pneumonectomy for NSCLC

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 5 years from surgery

    overall 5-year survival after empyema following pneumonectomy

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 23, 2013
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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