- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558350
Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery
March 14, 2012 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
15
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
-
-
-
Basel, Switzerland, 4031
- University Hospital Basel
-
-
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
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
all patients undergoing lobectomy or segmentectomy for lung cancer at a single institution
Description
Inclusion Criteria:
- elective lobectomy
- elective segmentectomy
- 20-90 years
- informed consent given
Exclusion Criteria:
- emergency operations
- pneumonectomy
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 |
---|
1
lobectomy / segmentectomy in patients with lung cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cytokine levels in blood, bronchial lavage fluid and pleural fluid
Time Frame: 2 years
|
2 years
|
Correlation between cytokine levels and pulmonary morbidity
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of this collective with transthoracic esophagectomies and evaluation of the inflammatory reactions (esophageal collective registered:NCT00512265)
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Urs Zingg, MD, University Hospital, Basel, Switzerland
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
April 1, 2007
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 14, 2007
Study Record Updates
Last Update Posted (Estimate)
March 15, 2012
Last Update Submitted That Met QC Criteria
March 14, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 68/07
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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