径向支气管内超声联合电磁导航支气管镜检查：NEBULA研究——一项随机对照试验
The addition of radial endobronchial ultrasound to electromagnetic navigation bronchoscopy: the NEBULA study - a randomised controlled trial.
作者
作者单位
- Odense Respiratory Research Unit (ODIN), Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
- Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark.
- Department of Respiratory Medicine and Infectious Disease, Bispebjerg Hospital, Copenhagen, Denmark.
- Department of Respiratory Medicine, Aalborg University Hospital, Aalborg, Denmark.
- Department of Respiratory Diseases and Allergology, Aarhus University Hospital, Aarhus, Denmark.
- Department of Internal Medicine, Vejle Hospital, Vejle, Denmark.
摘要
中文
支气管镜活检是诊断疑似恶性肿瘤的较小周围型肺部病变的重要工具。电磁导航支气管镜检查（ENB）用于引导支气管镜到达病变部位，径向支气管内超声（rEBUS）用于在到达后确认病变的存在。两种技术的联合应用可能提高诊断率，但目前仅有少数研究且结果不一。本研究旨在真实反映日常临床实践与挑战的实用场景下，探讨ENB+rEBUS联合应用是否优于单独ENB用于诊断疑似肺癌的周围型肺部病变。研究按照CONSORT指南实施。所有患者随机分配至ENB组或ENB+rEBUS组。参考标准为最终组织病理学诊断或6个月CT随访确定。采用意向性治疗分析，仅将具有明确诊断的操作归类为"诊断性"。四个中心共纳入200例患者，其中183例随机化并纳入最终分析。两组间诊断率无差异（43.8%对比45.7%），恶性病变诊断率及不良事件亦无差异。ENB+rEBUS是一种安全且耐受性良好的操作，但并不优于单独ENB。
English
Bronchoscopic biopsies are a valuable tool for diagnosing small peripheral lung lesions suspected of cancer. Electromagnetic navigation bronchoscopy (ENB) has been developed to guide the bronchoscopist to the lesion and radial endobronchial ultrasound (rEBUS) to confirm the presence lesion once reached. The combination of modalities might improve the diagnostic yield; however, only a few studies with diverting results have been published. The objective of the present study was to investigate whether the combination of rEBUS and ENB is superior to ENB alone for diagnosing peripheral lung lesions suspected of lung cancer in a pragmatic study setting representing the daily clinical practices and challenges. The study was conducted according to CONSORT guidelines. All patients were randomised for either ENB or ENB+rEBUS. The reference test was either a final histopathologic diagnosis or determined by 6 months of computed tomography surveillance. Analyses were performed using intention-to-treat, with only procedures with a definitive diagnosis categorised as "diagnostic". Of 200 patients included from four centres, 183 were randomised and included in the final analyses. There was no difference in diagnostic yield between the two groups (43.8% versus 45.7%), nor did we find any difference in malignant yield or adverse events. ENB+rEBUS is a safe and well-tolerated procedure, but not superior to ENB alone.
分类与指标
- 研究类型
- 临床研究
- 病种
- 肺癌
- JCR 分区
- Q1
- 影响因子
- 4.4
- 新锐分区
- 3区