TH-112: Pilot Study to Investigate The Diagnostic Yield and Utility of 22g and 19g Endobronchial Ultrasound Transbronchial Needle Aspirate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Compare diagnostic yield
研究概览
简要总结
Needle biopsy samples are routinely collected to evaluate cytomorphology, immunohistochemical markers and for mutational analysis. With regular use of immunotheraputic interventions, needle biospy has become more frequent and requires bigger samples for an increasing battery of tests. There has been no clear consensus on which biopsy needle yields the best biopsy sample. It is unclear if large 19g needle offers better yield than a 22 g needle. Although previous studies comparing 21, 22 and 19g needles have suggested that larger needles yield larger biopsy sizes, conflictng studies have shown that larger biopsies lead to bloodier samples with potentially smaller fragments of tissue, offering no improvement in diagnostic, yield, adequacy or sample size.
This study compares biopsy samples collected using 19g and 22g needles from patients of non small cell lung cancer (NSCLC) scheduled to undergo endobronchial ultrasound (EBUS) and transbroncial needle aspiration (TBNA).
详细描述
Primary Objective To compare the diagnostic yield of 22g and 19g EBUS transbronchial needle aspirate (TBNA)
Secondary Objectives
- To compare the sample adequacy of 22g and 19g EBUS TBNA
- To compare the sample quality of 22g and 19 g EBUS TBNA
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The needle size to be used first will be chosen by permuted block randomization scheme by the statistician
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
- •Patients undergoing EBUS TBNA for evaluation of lymphadenopathy, lung nodule or mass
- •Patients must have atypical lymph nodes. Atypical lymph nodes are characterized by >10mm in short axis or lymph nodes 5-10mm in short axis with atypical features.
- •Age > 18 years.
- •Patients must have platelets count > 50,000
- •Ability to understand and willingness to sign a written informed consent and HIPAA consent document
- •WOCBP must agree not to get pregnant until the day of the procedure
排除标准
- •Patients with uncorrectable coagulopathy will be excluded.
- •Patients with hemodynamic instability will be excluded
- •Patients with refractory hypoxemia will be excluded
- •Patients with therapeutic anticoagulant that cannot be held for 2 days before and 1 day after the procedure.
- •Patients who are unable to tolerate general anesthesia according to the anesthesiologist
- •Pregnant or breast feeding.
结局指标
主要结局
Compare diagnostic yield
时间窗: 1 year
Diagnostic yields of 22g and 19g needles will be evaluated by two blinded cytopathologists. Diagnostic yield refers to a specific diagnosis made on the basis of EBUS TBNA samples.
次要结局
- To compare the sample adequacy of 22g and 19g EBUS TBNA(1 year)
- To compare the sample quality of 22g and 19 g EBUS TBNA(1 year)