Purpose and Rationale. Management of emphysema involves a number of medications along with pulmonary rehabilitation. Recently, there have been reports that surgical resection of emphysematous lung tissue can allow the remaining normal tissue to expand and therefore provide better pulmonary function. This has been termed """"""""lung volume reduction surgery"""""""" (LVRS). Duke has been selected as one of eighteen medical centers around the country to participate in a randomized control trial of this form of surgery as compared to standard medical therapy and pulmonary rehabilitation. The specific hypothesis of the National Emphysema Treatment Trial (NETT) is that LVRS will provide improvement in pulmonary function, exercise tests, and quality of life as compared to conventional therapy with an acceptable surgical mortality/morbidity risk. Methods: This will be a multi center randomized trial involving over 4,000 patients. Patients will be randomized to either a surgical approach or to standard medical therapy after an extensive evaluation. An extensive evaluation will be done to evaluate the emphysema from a radiologic, clinical, and and physiologic perspective. Pulmonary rehabilitation will be offered to all subjects. Subjects then will be randomized to either receive the surgery or to continue in standard medical therapy. The surgery to be offered will be LVRS through either a median sternotomy or through vido assisted thoracospic procedures. Follow-up will involve exercise tests, pulmonary function tests, and quality of life assessments over the subsequent five years. Data from all eighteen centers will be analyzed at the Data Coordinating Center at Johns Hopkins University in Baltimore, Maryland. The study is designed to last at least five years. A data safety and monitoring board will review the data every six months to determine if the study should continue. Patients with emphysema, who are non-smokers and who are Medicare recipients, will be recruited. The NIH contract with Duke calls for at least 50 patients per year to be randomized. The fact that Duke has been selected has been publicized in the lay press and already we have several hundred patients on a waiting list to be considered. Additional patients will come from Duke referrals and other physician referrals throughout the Southeast. Patient selection will be determined on a number of physiologic tests (see detailed protocol attached). Randomization will be carried out at the Data Coordinating Center in Baltimore. Results: No results are available to date. Significance: Emphysema is an important national health problem. This study will help determine the optimal therapy for patients with this condition.
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