NCT05497271招募中不适用
Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions and Study of Its Application for Diagnosis, Treatment and Prognosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- diagnostic accuracy by cystic fluid analysis
研究概览
简要总结
Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 who diagnosed with pancreatic cystic lesion
- •patients who are able to acquire cystic fluid through EUS-FNA or surgery
- •patients aged 18 years and older
排除标准
- •patients who did not want to participate in this study
- •patients aged under 18 years old
- •severely mentally ill patients
- •pregnant women
结局指标
主要结局
diagnostic accuracy by cystic fluid analysis
时间窗: up to 5 years after cystic fluid analysis
diagnostic accuracy by cystic fluid analysis in comparison with pathologic diagnosis
次要结局
- Overall survival(up to 5 years after cystic fluid analysis or surgical resection)
- Malignant transformation rate(up to 5 years after cystic fluid analysis)
- Prediction for treatment response in case of surgical resected or EUS-guided ethanol ablated pancreatic cysts(up to 5 years after cystic fluid analysis or EUS guided ablative therapy)
- Cytology of cystic fluid(within 2 months after study enrollment)
- Disease free survival(up to 5 years after cystic fluid analysis or surgical resection)
- Chemical profile of Amylase in cystic fluid(within 2 months after study enrollment)
- Chemical profile of CEA in cystic fluid(within 2 months after study enrollment)
- Chemical profile of glucose in cystic fluid(within 2 months after study enrollment)
- DNA mutation profile of cystic fluid(within 2 months after study enrollment)
研究者
Sang Hyub Lee
Professor
Seoul National University Hospital
研究点 (1)
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