A Multi-center Study Comparing Standard 22-gauge and 22-gauge ProCore Needles for Endobronchial Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- Quality of tumor obtained (measured by cell block and ability to perform mutational analysis)
研究概览
简要总结
The purpose of this study is to compare the usefulness of two needles (used for obtaining a lung tissue sample : (1) standard 22-gauge, and (2) ProCore 22-gauge) for endobronchial ultrasound
详细描述
The purpose of this study is to compare the usefulness of two needles used for obtaining a lung tissue sample: (1) standard 22-gauge, and (2) ProCore 22-gauge. Both of these needles are used to get biopsies (samples) of lung tissue. The standard needle has one bevel (angled side of the needle formed when it is sharpened to make a point), while the ProCore needle has 2 bevels. The standard needle is more commonly used and we are doing this study to see if the ProCore needle would be more useful.
The investigator in charge of this study is Dr. Nichole T. Tanner. This study is being done at four sites and will involve approximately 200 volunteers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with known or suspected lung cancer with mediastinal adenopathy as defined by a mediastinal lymph node >1 cm in short axis or a normal sized lymph node with uptake on FDG-PET scan that is higher than background PET activity.
- •Participants must be at least 18 years old or older, lack bleeding disorders, and be able to provide informed consent. The latter two criteria will be assessed from the patient's history and the consenting interview.
排除标准
- •Subjects who refuse to participate, or demonstrate inability to give informed consent
- •Subjects who are less than 18 years of age
- •Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
- •Subjects with suspected sarcoidosis, lymphoma, or metastatic cancer from other sites (i.e. those without a known or suspected lung primary)
- •Subjects on anticoagulation (other than Aspirin) whom cannot have their anticoagulation held for the procedure due to other clinical reasons (i.e. recent cardiac stent placement).
研究组 & 干预措施
22-gauge Standard Needle
Participants will have each node sampled starting with the standard 22G needle on the first pass followed by the ProCore 22G needle on the second pass (for a total of 8 passes)
干预措施: 22-gauge Standard Needle (Other)
22-gauge ProCore Needle
Participants will have each node sampled starting with the ProCore 22G on the first pass followed by the standard 22G needle on the second pass (for a total of 8 passes)
干预措施: 22-gauge ProCore Needle (Other)
结局指标
主要结局
Quality of tumor obtained (measured by cell block and ability to perform mutational analysis)
时间窗: Within two weeks from the day of the procedure
Ease of use of 22-gauge ProCore EBUS needles and the standard 22-gauge needles.
时间窗: Within two weeks from the day of the procedure
Quantity of tissue obtained (measured by number of unstructured fragments)
时间窗: Within two weeks from the day of the procedure
次要结局
未报告次要终点