LUNG VOLUME REDUCTION SURGERY--CLINICAL CENTER

肺减容手术--临床中心

• 批准号: 2423457
• 负责人: LARRY R KAISER
• 金额: $ 15.57万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-12-20 至 2003-12-19
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2423457
• 关键词: clinical research; cooperative study; data collection; emphysema; health care personnel education; human subject; human therapy evaluation; lung; outcomes research; patient /disease registry; respiratory airway volume; respiratory disorder chemotherapy; respiratory function; statistics /biometry; thoracic surgery

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.

总体目标是支持七年多中心