Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions----A Multiple Center,Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Rate of change of diagnosis
研究概览
简要总结
It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.
详细描述
First, the investigators will send only EUS images of patients with PCL to diagnosis committee that is consisted with 8 EUS specialists from different countries.The diagnosis will be collected. Then the investigators send the results of EUS-FNA. The diagnosis and suggestions will be collected again. The investigators will calculate how much diagnosis has been changed because of results of EUS-FNA. The investigators will also follow up these patients for 5 years at least to find if these patients benefit from EUS-FNA and complications such as needle tract seeding metastases.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with ages from 18-80 years old.
- •The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm.
- •Sign the informed consent voluntarily. -
排除标准
- •The patient can't accept the endoscopic procedure.
- •The patient has blood coagulation dysfunction.
- •The patient has mental disorders.
- •The patient has mild or severe cardiorespiratory insufficiency.
- •The patient has hypertension and can't be controlled to safe level.
- •Patients with alcohol dependence.
- •Pregnant and lactating women.
- •The patients the investigators don't think suitable for this study.
结局指标
主要结局
Rate of change of diagnosis
时间窗: During 2 weeks
Finish diagnosis before and after getting the results of EUS-FNA
次要结局
- Number of Participants with Adverse Events(5 years)
研究者
Xiaoyin Zhang
Associate professor
Air Force Military Medical University, China