EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis
研究概览
简要总结
Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate histology obtained.
Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Esophageal, gastric, or duodenal SET over 2 cm
- •Hypoechoic lesion including 4th layer on EUS
排除标准
- •SET with characteristic findings such as lipoma, vessels, or ectopic pancreas
- •bleeding or rupture of SET
- •platelet count <50,000 or prothrombin time INR > 1.3
结局指标
主要结局
Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis
时间窗: 12 months
Gold standard diagnosis is defined as; 1. in operated patients; histological assessment of the surgical resection specimen 2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies)
次要结局
未报告次要终点
研究者
Kee Don Choi
Associate professor
Asan Medical Center