Patients with severe emphysema are being enrolled in a major, nationwide study -- the National Emphysema Treatment Trial (NETT) -- conducted at Cedars-Sinai Medical Center, one of 17 sites in the U.S. Funded by the National Institutes of Health and the Health Care Financing Administration, the study is comparing the outcomes of emphysema patients who receive maximum medical therapy with those who undergo medical therapy in combination with lung volume reduction surgery. All testing, transportation and accommodations are provided free of charge to patients enrolled in the study.
"To date, we've screened 90 patients, and enrolled 32 in the study," says medical director of the trial Zab Mohsenifar, M.D., director of the Division of Pulmonary/Critical Care Medicine, who is working with Cedars-Sinai thoracic surgeon Robert McKenna, principal surgeon on the project. "Of those enrolled, about 16 have undergone surgery, and all are doing well."
Cedars-Sinai, one of two sites in California, is enrolling patients throughout the Western U.S., including Arizona, Nevada, Oregon and Utah. The process begins with a thorough examination to determine eligibility for the study. Those identified with significant emphysema and who agree to participate in the trial are initially placed in an eight-week rehabilitation study that combines an exercise program with a moderate medical treatment regimen.
"After patients complete this first phase, we repeat the testing, which includes extensive studies of the lungs and heart," explains Dr. Mohsenifar, who emphasizes that this comprehensive testing estimated at $50,000 per patient is available at no charge to participants. "Enrollees are then randomized into one of two arms of the study: one group receives maximum medical therapy with intensive rehabilitation and monitoring, and the second group undergoes lung volume reduction surgery with follow-up therapy and evaluation."
The surgery is performed to relieve pressure on the lower portion of the lungs caused by expansion of large air sacs in the upper region. Performed via a thorocoscopy, the procedure involves making two tiny holes in the chest through which approximately 30 percent of the upper portion of the lungs is removed. The procedure may also be done through an incision in the sternum.
"If you imagine the lungs as a slinky, the top coils are wide open in emphysema patients and press on the remaining coils below, inhibiting breathing," explains Dr. Mohsenifar. "By removing the top coils, the remaining lung opens up, easing breathing for these patients."
The surgery requires a seven- to 10-day hospital stay, and includes inpatient and outpatient therapy. Follow-up examinations are scheduled every six months for three to five years. "As we compare the outcomes of patients in the two groups, weíll be looking at such factors as ability to exercise, longevity and other related issues," he states.
Nationally, 561 patients have been enrolled since the study began in 1998, and approximately half have received the lung volume reduction surgery. Total NETT enrollment is expected to reach 2,500.
More information on NETT is available by contacting nurse coordinator Carol Geaga at 310-423-1842.
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