Endothelial Dysfunction As A Predictor Of Perioperative Outcome In Major Thoracic Surgery - An Observational Study
A small group of patients (about 12 out of every 100) are at risk of developing
complications, for example lung infection, after their surgery. Researchers do not always
know which patient is at risk or the reason why some patients develop these complications.
Your participation in this study may help researchers to understand who is at risk and also
the mechanism of some of the complications.
The inner layer of cells of blood vessels are called endothelial cells. This layer of cells
plays a vital role in the normal function of blood vessels, including blood clotting and
inflammation. Certain conditions, such as aging, smoking, high cholesterol, and some
chemotherapies cause these cells to not function properly. Researchers can test whether
these cells function properly by doing two simple tests - one is a blood test and the other
uses ultrasound and temperature probes on the finger to look at the ability of arm blood
vessels to dilate (expand).
The way your cells function will be tested within a month before your scheduled chemotherapy
/ radiation (if applicable), and again within a month before your major chest surgery. This
will be done on those patients with surgery planned or scheduled.
About 2 tablespoons of blood will be drawn to measure the number of circulating blood cells
that become endothelial cells.
During your scheduled surgery, the researcher will also collect just over a teaspoon of
blood at the beginning of the surgery for an additional endothelial risk assessment and a
small sample of lung tissue, if available. Tissue removed during long surgery is usually
thrown away if it is not needed for diagnosis and or treatment purposes. The lung tissue
sample collected for this research study will only be taken from lung tissue that is to be
discarded. The lung tissue will be used to determine the amount of a naturally occurring
substance thought to play a role in recruiting blood cells to repair injured lung tissue.
Blood samples (about 2 tablespoons) will also be collected after exercise, during your
surgery, 24 hours after your surgery, and at 5 days after surgery or the time you discharge
from the hospital (which ever is shorter). These blood samples will also be collected at
your routinely schedule post operative clinic visits at 1 month, 6 months, and 1 year after
surgery. The samples will be used to determine the amount of endothelial cells in the blood
For healthy volunteers, blood samples (about 2 tablespoons) will be collected at baseline
(prior to exercising), 15-30 minutes past peak exercise, 3 hours past peak exercise and at
24 hours past past peak exercise.
Data will be collected on you for 30 days after your surgery, and during the 1 year
follow-up. These data will then be matched with the amount of cell function as measured
before surgery to see if these tests may be used to help predict which patients are at
increased risk for complications. No other measurements will be done and this study will
not change your surgical procedure or lengthen your hospital stay.
This is an investigational study. About 90 patients will take part in this study. All
will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
Observational Model: Case Control, Time Perspective: Prospective
Number of Patient Major Pulmonary Events (MPE)
Baseline (entry in study) to end of study (estimated 1 year post-operative)
Reza-John Mehran, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|