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临床试验/NCT02360306
NCT02360306已完成不适用

The Analysis of the EBUS Scope as a Hybrid Bronchoscope

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Procedures able to be performed succesfully by Hybrid EBUS

研究概览

简要总结

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is widely used in the diagnosis of mediastinal and hilar adenopathy as well as in staging in lung cancer patients. Many studies have confirmed the utility of EBUS-TBNA with high sensitivity, specificity, and accuracy for the diagnosis of mediastinal and hilar adenopathy. 1-3 Less well reported has been the use of the EBUS bronchoscope to perform other procedures such as transbronchial biopsy (TBBx), endobronchial biopsy (EBBx), bronchoalveolar lavage (BAL) and airway brushings. While not well reported in the medical literature, anecdotal evidence supports these practices. The investigators propose a methodological evaluation of the full spectrum of procedures that have been performed and that are possible using an EBUS bronchoscope.

详细描述

  1. Objectives (include all primary and secondary objectives)

Primary objective - To study and more fully describe the full spectrum of procedures performed using an EBUS bronchoscope outside of EBUS-TBNA. 2. Background (briefly describe pre-clinical and clinical data, current experience with procedures, drug or device, and any other relevant information to justify the research)

There currently exists only anecdotal evidence and individual reports of the use of EBUS bronchoscopes in the performance of non-EBUS-TBNA procedures. Given the full size working channel through which all standard bronchoscopic tools are able to pass, the EBUS bronchoscope has been reported to have been used in the performance of other procedures such as BAL, TBBx, EBBx and airway brushing. Frequently during bronchoscopic procedures in which EBUS-TBNA is used to sample lymph nodes within the hilum and mediastinum there exists a need to perform other procedures including but not limited to those listed above. In these cases, the EBUS bronchoscope is removed and exchanged for a standard video bronchoscope often times dirtying the scope for only a single procedure. We routinely use EBUS bronchoscopy in our daily practice as interventional pulmonologists and would like to study the use of these bronchoscopes in the performance of procedures other than TBNA perhaps in an effort to more fully understand the benefits and limitations associated with the use of an EBUS bronchoscope during conventional video bronchoscopy. 3. Study Procedures

  1. Study design

We plan to collect the data for all clinically indicated procedures using an EBUS bronchoscope over a twelve month time frame in the JHH outpatient endoscopy suite. No procedures will be performed for research purposes. No additional procedures will be performed outside the scope of standard practice. 2. Study duration and number of study visits required of research participants. 12 month study duration, no research visits will be required. 3. Justification of why participants will not receive routine care or will have current therapy stopped.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing bronchoscopy involving the use of an EBUS bronchoscope in the Johns Hopkins endoscopy suite over the course of the study period

排除标准

  • Patients not able to safely undergo bronchoscopy as judged by the Interventional Pulmonary service and Anesthesia. This follows standard clinical practice

结局指标

主要结局

Procedures able to be performed succesfully by Hybrid EBUS

时间窗: twelve months

Procedures able to be performed succesfully by Hybrid EBUS in comparison to Conventional EBUS. This will be assessed using a case report form that includes a checklist of various procedures (e.g. TBNA, transbronchial forcep biopsy)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lonny Yarmus

Assistant Professor of Medicine

Johns Hopkins University

研究点 (2)

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