LUNG VOLUME REDUCTION SURGERY--CLINICAL CENTER

总体目标是支持七年多中心 与预期注册相关的随机临床试验。 本节目将研究肺容量减少的作用 手术(LVRS)治疗终末期肺气肿的评价 左肺减容术对功能、发病率和死亡率的远期疗效 并为该程序定义适当的患者选择标准。一个 次要目标是定义哪些患者从 做手术。研究人群将包括2600名患者。这个 研究将分三个阶段进行。第一阶段(9个月) 为制定一项议定书和操作手册以及 人员的招聘和培训。在这一阶段，临床 中心将与其他临床中心研究人员充分合作 和临床协调中心的研究人员正在开发 研究方案和操作手册。第二期(63 月)将用于招募患者、随机和 对受试者进行跟踪调查。第三阶段(12个月)将用于分析 描述研究结果的数据和手稿的撰写。 在第三阶段，临床中心的工作人员将与其他 研究调查员和项目官员进行决赛 对数据进行分析并撰写描述研究结果的手稿 学习。

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.