LUNG VOLUME REDUCTION SURGERY--CLINICAL CENTER

肺减容手术--临床中心

• 批准号: 2421087
• 负责人: JOEL D COOPER
• 金额: $ 8.8万
• 依托单位: WASHINGTON UNIVERSITY
• 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/2421087
• 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.

总体目标是支持一个七年的多中心 随机临床试验与前瞻性注册中心相关。 该计划将检查减少肺部的作用 手术（LVR）在治疗末期肺气肿方面，评估 LVR关于功能，发病率和死亡率的长期结果 并为该过程定义适当的患者选择标准。 一个 次要目标是定义哪个患者从中受益最大 外科手术。 研究人群将由2600名患者组成。 这 研究将分为三个阶段。 第一阶段（9个月）将是 制定操作协议和手册 人员招募和培训。 在此阶段，临床 中心将与其他临床中心调查人员完全合作 以及开发中的临床协调中心研究人员 研究方案和操作手册。 第二阶段（63 几个月）将用于招募患者，随机分组和 受试者的随访。 第三阶段（12个月）将用于分析 描述研究结果的手稿的数据和撰写。 在第三阶段，临床中心工作人员将与其他 研究调查人员和项目官员进行最终 分析数据并编写手稿，描述 学习。

项目成果

Genetic association analysis of COPD candidate genes with bronchodilator responsiveness.

• DOI: 10.1016/j.rmed.2008.10.025
• 发表时间: 2009-04
• 期刊: RESPIRATORY MEDICINE
• 影响因子: 4.3
• 作者: Kim, Woo Jin;Hersh, Craig P.;DeMeo, Dawn L.;Reilly, John J.;Silverman, Edwin K.
• 通讯作者: Silverman, Edwin K.

Weight gain after lung reduction surgery is related to improved lung function and ventilatory efficiency.

肺减容手术后的体重增加与肺功能和通气效率的改善有关。

• DOI: 10.1164/rccm.201203-0538oc
• 发表时间: 2012
• 期刊: American journal of respiratory and critical care medicine
• 影响因子: 24.7
• 作者: Kim,Victor;Kretschman,DanaM;Sternberg,AliceL;DeCampJr,MalcolmM;Criner,GerardJ;NationalEmphysemaTreatmentTrialResearchGroup
• 通讯作者: NationalEmphysemaTreatmentTrialResearchGroup