NIHR Respiratory Disease, Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, Imperial College London, London, UK.
Thorax Centre, Barts Health NHS Trust, London, UK.
BMJ Open. 2018 Oct 17;8(10):e021368. doi: 10.1136/bmjopen-2017-021368.
Although lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision-making.
We describe the protocol of the CELEB study, a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, airflow obstruction, dyspnoeaand exercise capacity (incremental shuttle walk test).
Ethical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter.
ISRCTN19684749; Pre-results.
尽管肺减容手术和支气管镜下肺减容术联合支气管内活瓣置入术均已被证明可改善肺气肿患者的肺功能、运动能力和生活质量，但这两种手术之间尚无直接比较数据来为临床决策提供信息。
我们描述了 CELEB 研究的方案，这是一项随机对照试验，将使用包含体重指数、气流阻塞、呼吸困难和运动能力（递增穿梭步行试验）的综合疾病严重程度指标 iBODE 评分，比较两种手术在 1 年时的结局。
已从伦敦富勒姆研究伦理委员会（Fulham Research Ethics Committee）获得开展该研究的伦理批准（16/LO/0286）。该试验的结果将为该人群的治疗选择提供信息，并将在国内外会议上进行报告，并发表在同行评议的期刊上。我们还将在一封信中向所有参与者传达主要结果。
ISRCTN82006265；预结果。
