Evaluation of the Mediastinal Lymph Nodes With Endobronchial-Guided Transbronchial Needle Aspiration in Individuals With Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Evidence that is consistent with lung disease and presentation of enlarged mediastinal lymph nodes
研究概览
简要总结
The purpose of this protocol is to obtain biologic materials from the mediastinal lymph nodes from patients with lung disease and mediastinal lymph node involvement in order to: (1) develop a better understanding of the cause and development of lung disorders involving the mediastinal lymph nodes; (2) identify biologic parameters that help diagnose and predict the behavior of human lung diseases; and (3) identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs.
详细描述
This study will use bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) as part of their diagnostic work up as recommended by the treating physician. The procedure will be performed as standard of care, either under general anesthesia in the operating room or in the bronchoscopy suite under moderate sedation and analgesia. Bronchoscopy with EBUS-TBNA is normally an ambulatory procedure. During the procedure, biopsy needle will be passed through the tube and a small sample will be taken for both diagnostic and research purposes. Samples collected for diagnostic purposes will be sent to the Department of Pathology. Additional biopsy samples will be collected for research purposes. The subject is observed after the bronchoscopy, including vital signs and level of consciousness, until they are back to baseline. All subjects will be discharged with an escort as per Hospital policy. An overnight stay would be required for ambulatory individuals only if the individual is not, in the judgment of the treating attending physician, safe to be discharged as is standard practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must provide informed consent
- •Males and females, age 18 years and older
- •Lung disease proven by at least one of the following:
- •symptoms consistent with pulmonary disease
- •chest X-ray and chest CT and/or PET CT scan consistent with lung disease and mediastinal lymph node involvement
- •lung biopsy consistent with lung disease known to involve mediastinal lymph nodes
- •patients with diseases of organs with known association to lung disease and mediastinal lymph node involvement.
- •Undergoing fiberoptic bronchoscopy with EBUS-TBNA as dictated by their standard clinical care
排除标准
- •Patient refuses consent.
- •Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, or any local anesthetic will not be included in the study
- •Individuals who cannot tolerate general anesthesia or moderate sedation and analgesia
结局指标
主要结局
Evidence that is consistent with lung disease and presentation of enlarged mediastinal lymph nodes
时间窗: 24 Hours
Bronchoscopy with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
次要结局
未报告次要终点