PDF(Pubmed)
Abstract：
BACKGROUND: Application of vapour ablation as a novel approach to lung volume reduction has positive effects in patients with severe emphysema. The BENTO study is a randomised, controlled, open, multicentre trial, to assess the effects of bronchoscopic thermal vapour ablation (BTVA) in the German healthcare system.
METHODS: Patients with bilateral heterogeneous emphysema of the upper lobes in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3/4 will be enrolled in this trial and will receive either standard medical management alone (according to GOLD guidelines) or BTVA treatment with the InterVapor system together with standard medical management. Patients will be randomised in a 2:1 ratio (treatment group:control group). A total of 224 patients will be enrolled at 15 study sites. The primary endpoint is the change in patient-reported disease-specific quality of life, as measured by the St George\'s Respiratory Questionnaire for chronic obstructive pulmonary disease patients between randomisation and the 9-month follow-up visit. Secondary endpoints include adverse events, mortality, vital status, changes in lung function parameters, exercise capacity and other efficacy measures at 3, 9 and 12 months.The BENTO trial was commissioned by the German Federal Joint Committee, to demonstrate that this approach is an efficient and safe treatment option in the German healthcare system.
BACKGROUND: The protocol has been approved by the lead ethics committee in Germany (Ethics Committee of the Medical Faculty of Heidelberg) and until present also by the following ethics committees: Ethics Committee of the Medical Faculty of Duisburg-Essen, Ethics Committee of the Medical Faculty of Martin-Luther-University Halle-Wittenberg, Ethics Committee of the State Medical Association of Hessen, Ethics Commission of the State Office for Health and Social Affairs of the State of Berlin, Ethics Committee of the Medical Faculty of Greifswald. The results will be published in a peer-reviewed journal.
BACKGROUND: NCT05717192.
METHODS: Patients with bilateral heterogeneous emphysema of the upper lobes in Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 3/4 will be enrolled in this trial and will receive either standard medical management alone (according to GOLD guidelines) or BTVA treatment with the InterVapor system together with standard medical management. Patients will be randomised in a 2:1 ratio (treatment group:control group). A total of 224 patients will be enrolled at 15 study sites. The primary endpoint is the change in patient-reported disease-specific quality of life, as measured by the St George\'s Respiratory Questionnaire for chronic obstructive pulmonary disease patients between randomisation and the 9-month follow-up visit. Secondary endpoints include adverse events, mortality, vital status, changes in lung function parameters, exercise capacity and other efficacy measures at 3, 9 and 12 months.The BENTO trial was commissioned by the German Federal Joint Committee, to demonstrate that this approach is an efficient and safe treatment option in the German healthcare system.
BACKGROUND: The protocol has been approved by the lead ethics committee in Germany (Ethics Committee of the Medical Faculty of Heidelberg) and until present also by the following ethics committees: Ethics Committee of the Medical Faculty of Duisburg-Essen, Ethics Committee of the Medical Faculty of Martin-Luther-University Halle-Wittenberg, Ethics Committee of the State Medical Association of Hessen, Ethics Commission of the State Office for Health and Social Affairs of the State of Berlin, Ethics Committee of the Medical Faculty of Greifswald. The results will be published in a peer-reviewed journal.
BACKGROUND: NCT05717192.
摘要：
背景：蒸气消融作为一种新的肺减容术对严重肺气肿患者具有积极作用。BENTO研究是一项随机研究，控制,打开,多中心试验,评估德国医疗保健系统中支气管镜热蒸汽消融（BTVA）的效果。
方法：在全球慢性阻塞性肺疾病倡议（GOLD）3/4期中患有上叶双侧异质性肺气肿的患者将被纳入本试验，并将单独接受标准医疗管理（根据GOLD指南）或使用InterVapor系统进行BTVA治疗以及标准医疗管理。患者将以2:1的比例随机分组(治疗组:对照组)。共有224名患者将在15个研究地点登记。主要终点是患者报告的疾病特异性生活质量的变化，根据随机分组和9个月随访之间慢性阻塞性肺疾病患者的圣乔治呼吸问卷测量。次要终点包括不良事件，死亡率,生命状态,肺功能参数的变化，3、9和12个月时的运动能力和其他功效测量。本托审判是由德国联邦联合委员会委托进行的,证明这种方法在德国医疗保健系统中是一种有效和安全的治疗选择。
背景：该方案已获得德国领导伦理委员会（海德堡医学院伦理委员会）的批准，直到目前还获得以下伦理委员会的批准：杜伊斯堡-埃森医学院伦理委员会，马丁路德大学医学院伦理委员会，黑森州医学协会伦理委员会，柏林国家卫生和社会事务办公室道德委员会，格赖夫斯瓦尔德医学院伦理委员会。结果将发表在同行评审的期刊上。
背景：NCT05717192。
方法：在全球慢性阻塞性肺疾病倡议（GOLD）3/4期中患有上叶双侧异质性肺气肿的患者将被纳入本试验，并将单独接受标准医疗管理（根据GOLD指南）或使用InterVapor系统进行BTVA治疗以及标准医疗管理。患者将以2:1的比例随机分组(治疗组:对照组)。共有224名患者将在15个研究地点登记。主要终点是患者报告的疾病特异性生活质量的变化，根据随机分组和9个月随访之间慢性阻塞性肺疾病患者的圣乔治呼吸问卷测量。次要终点包括不良事件，死亡率,生命状态,肺功能参数的变化，3、9和12个月时的运动能力和其他功效测量。本托审判是由德国联邦联合委员会委托进行的,证明这种方法在德国医疗保健系统中是一种有效和安全的治疗选择。
背景：该方案已获得德国领导伦理委员会（海德堡医学院伦理委员会）的批准，直到目前还获得以下伦理委员会的批准：杜伊斯堡-埃森医学院伦理委员会，马丁路德大学医学院伦理委员会，黑森州医学协会伦理委员会，柏林国家卫生和社会事务办公室道德委员会，格赖夫斯瓦尔德医学院伦理委员会。结果将发表在同行评审的期刊上。
背景：NCT05717192。
