EUS-B-FNA vs EUS-FNA for Left Adrenal Gland Analysis in Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- The proportion of patients with a successful EUS-B-FNA procedure for LAG analysis.
研究概览
简要总结
The purpose of this study is to compare EUS-B-FNA (using the EBUS scope)with EUS-FNA for left adrenal gland analysis in lung cancer patients.
详细描述
Rationale:
The adrenal glands are a predilection site for distant metastases (M1b) in patients with lung cancer.
However, even in a patient with a confirmed lung cancer an enlarged adrenal lesion is still more likely to be benign than to be malignant(4). Therefore tissue sampling of the left adrenal gland (LAG) is obligatory to either confirm or rule out metastases. Sampling is regularly performed by a transgastric endoscopic approach using a conventional GI-EUS scope. The aim of this study is investigate the success rate of endoscopic ultrasound guided fine-needle aspiration using the EBUS scope (EUS-BFNA) for left adrenal gland analysis in patients with lung cancer and an on imaging suspected left adrenal gland.
Hypothesis:
EUS-B guided transgastric FNA of suspected left adrenal glands (LAG) reduces the need for conventional EUS- FNA by half.
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
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
- •(Suspected) Lung Cancer
- •For malignancy suspected LAG on imaging (enlarged based on CT and/or FDG avid based on FDG-PET);
- •Indication for endosonographic mediastinal staging by EBUS;
- •Indication for LAG sampling;
排除标准
- •Contraindication for EUS;
- •Pregnancy;
结局指标
主要结局
The proportion of patients with a successful EUS-B-FNA procedure for LAG analysis.
时间窗: within 3 weeks after inclusion
Successful is defined as: LAG is visible, sampling is possible and adequate material for cytopathological evaluation is obtained.
次要结局
未报告次要终点
研究者
Prof J.T. Annema
Prof Dr
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)