Endoscopic Ultrasound-guided Fine Needle Tissue Acquisition With 22- and 25-gauge ProCore Needle in Solid Pancreatic and Peripancreatic Masses: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
Background:
EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet.
Aim:
To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)
详细描述
Patient and methods:
Patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic confirm. These patients were randomly assigned to 22 gauge or 25 gauge group.
Procedure:
They underwent EUS-guided FNA, 3 times with 10 times of to-and pro movement each.
The number of patients required:
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
- Double (Participant, Care Provider)
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 agree to participate in research
- •18 years of age and older patients
- •Patients who have pancreatic or peripancreatic mass in imaging studies
排除标准
- •Contraindication to endoscopy
- •Patients younger than 18 years old
- •Bleeding tendency
- •Cardiopulmonary dysfunction
结局指标
主要结局
Diagnostic accuracy
时间窗: October. 2014
Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis
次要结局
- Technical success(October. 2014)
研究者
Kwang Hyuck Lee
Assistant Professor of Medicine, Division of Gastroenterology
Samsung Medical Center