Macroscopic On-site Quality Evaluation of Biopsy Specimens to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions: a Multicenter Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
研究概览
简要总结
The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain.
The objective of this study is to evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis.
详细描述
To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis in a randomized controlled study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for intestinal or extra-intestinal solid lesions more than 2cm in the largest diameter would be included.
排除标准
- •Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.
研究组 & 干预措施
Macroscopic on-site evaluation
EUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation.
干预措施: Macroscopic on-site evaluation (Procedure)
Control
EUS-FNA perform with a 19-gauge needle with conventional techniques.
干预措施: Control (Other)
结局指标
主要结局
Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
时间窗: 4 weeks
proportion of patients with adequate tissue for diagnosis obtained by EUS FNA
次要结局
未报告次要终点
研究者
Charing Chong, MD
Assistant Professor
Chinese University of Hong Kong