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Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00558350
First received: November 13, 2007
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

Inflammatory reaction in different compartments of the body may have a negative effect on outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the pleural space is high compared to the systemic and intrapulmonary ones.


Condition
Lung Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Cytokine levels in blood, bronchial lavage fluid and pleural fluid [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Correlation between cytokine levels and pulmonary morbidity [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of this collective with transthoracic esophagectomies and evaluation of the inflammatory reactions (esophageal collective registered:NCT00512265) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
lobectomy / segmentectomy in patients with lung cancer

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

all patients undergoing lobectomy or segmentectomy for lung cancer at a single institution

Criteria

Inclusion Criteria:

  • elective lobectomy
  • elective segmentectomy
  • 20-90 years
  • informed consent given

Exclusion Criteria:

  • emergency operations
  • pneumonectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558350

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Urs Zingg, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00558350     History of Changes
Other Study ID Numbers: 68/07
Study First Received: November 13, 2007
Last Updated: March 14, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
lobectomy
inflammatory reaction
intrapulmonary
intrapleural

Additional relevant MeSH terms:
Neoplasms
Inflammation
Lung Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013