A Prospective Comparison of SurePath™ Liquid -Based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Esophageal, Gastric, Duodenal Subepithelial Tumors, Periesophageal and Perigastric Lymph Nodes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ultrasound-guided sampling.
详细描述
The SurePath™ has been approved by the FDA since 1997. Investigators want to compare the diagnostic accuracy of SurePath™ liquid based cytology and conventional smear cytology(CSC) in EUS-FNA sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.
The investigators randomly assigned (1:1) patients to the SurePath™ group or the CSC group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. The aim of this study is to confirm that the SurePath™ is not inferior than the conventional smear test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed the agreement after the explanation
- •Patients suspected of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes from radiological(CT, MR, ultrasound) or endoscopic examinations.
排除标准
- •Those who did not agree with the study
- •Patients younger than 19 years of age
- •Serious mental patients
- •Patients with severe accompanying diseases (ESRD, advanced COPD, severe heart failure, sever mental illness)
- •Pregnant women
- •If EUS is difficult due to previous surgery (Billroth II or TG with R-en-Y)
- •Patient with blood clotting abnormality
- •If there is a risk of tract seeding after examination
结局指标
主要结局
Diagnostic accuracy
时间窗: 6 months after randomization
Pathologic results of the surgical specimen or core needle biopsy will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. The combined results make a final diagnosis and are compared between two groups.
次要结局
- Cytomorphologic feature(6 months after randomization)
研究者
Soo-Jeong Cho
Clinical associate professor
Seoul National University Hospital