The overall objective is to support a seven year multi-centered randomized clinical trial in association with a prospective registry. This program will examine the role of Lung Volume Reduction Surgery (LVRS) in the treatment of end-stage emphysema, evaluate the long term outcome of LVRS on function, morbidity and mortality and define appropriate patient selection criteria for the procedure. A secondary objective is to define which patients benefit most from the surgery. The study population will consist of 2,600 patients. The study will be conducted in three phases. Phase I (9 Months) will be for development of a protocol and manual of operations and recruitment and training of personnel. During this phase the clinical centers will collaborate fully with other clinical center investigators and the clinical coordinating center investigators in the development of the study protocol and manual of operations. Phase II (63 Months) will be for recruitment of patients, randomization and follow-up of subjects. Phase III (12 Months) will be for analysis of data and writing of manuscripts describing results of the study. During phase III, clinical center staff will collaborated with other study investigators and the project officer to conduct the final analyses of the data and to write manuscripts describing results of the study.

Agency
National Institute of Health (NIH)
Institute
Division of Lung Diseases (NHLBI)
Type
Research and Development Contracts (N01)
Project #
N01HR076118-000
Application #
2421088
Study Section
Project Start
1996-12-20
Project End
2003-12-19
Budget Start
1996-12-20
Budget End
1997-09-30
Support Year
Fiscal Year
1997
Total Cost
Indirect Cost
Name
University of Washington
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
135646524
City
Seattle
State
WA
Country
United States
Zip Code
98195
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Kaplan, Robert M; Sun, Qiankun; Ries, Andrew L (2015) Quality of well-being outcomes in the National Emphysema Treatment Trial. Chest 147:377-387
Minai, Omar A; Fessler, Henry; Stoller, James K et al. (2014) Clinical characteristics and prediction of pulmonary hypertension in severe emphysema. Respir Med 108:482-90
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Kaplan, Robert M; Sun, Qiankun; Naunheim, Keith S et al. (2014) Long-term follow-up of high-risk patients in the National Emphysema Treatment Trial. Ann Thorac Surg 98:1782-9
Kim, Victor; Sternberg, Alice L; Washko, George et al. (2013) Severe chronic bronchitis in advanced emphysema increases mortality and hospitalizations. COPD 10:667-78
Benzo, Roberto; Siemion, Wendy; Novotny, Paul et al. (2013) Factors to inform clinicians about the end of life in severe chronic obstructive pulmonary disease. J Pain Symptom Manage 46:491-499.e4
Zhou, Xiaobo; Qiu, Weiliang; Sathirapongsasuti, J Fah et al. (2013) Gene expression analysis uncovers novel hedgehog interacting protein (HHIP) effects in human bronchial epithelial cells. Genomics 101:263-72
Kim, Victor; Kretschman, Dana M; Sternberg, Alice L et al. (2012) Weight gain after lung reduction surgery is related to improved lung function and ventilatory efficiency. Am J Respir Crit Care Med 186:1109-16
Chandra, Divay; Wise, Robert A; Kulkarni, Hrishikesh S et al. (2012) Optimizing the 6-min walk test as a measure of exercise capacity in COPD. Chest 142:1545-1552

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