Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Sensitivity of EUS-FNA With StandardTechnique
研究概览
简要总结
The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for solid pancreatic lesions. Investigators hope to discover the best technique for obtaining diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and fine needle aspirate procedure.
There are currently several techniques for obtaining tissue during endoscopic ultrasound and fine needle aspirate. The procedure will be performed by either the capillary suction technique or no suction technique.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-patients and out-patients between the age of 18years and 90 years with pancreatic masses presenting for EUS-FNA
排除标准
- •Uncorrectable coagulopathy (INR > 1.5)
- •Uncorrectable thrombocytopenia (platelet < 50,000)
- •Uncooperative patients
- •Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- •Refusal to consent form
- •Cystic lesions
- •Inaccessible lesions to EUS
结局指标
主要结局
Sensitivity of EUS-FNA With StandardTechnique
时间窗: 6 months
Sensitivity of the EUS-FNA with Capillary technique
Sensitivity of EUS-FNA
时间窗: 6 months
Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions
Diagnostic Yield of Standard Technique
时间窗: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Diagnostic Yield of Capillary Technique
时间窗: up to 6 months
Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.
Sensitivity of EUS-FNA With Capillary Technique
时间窗: 6 months
Sensitivity of the EUS-FNA with Capillary technique
次要结局
- First Pass Diagnostic Rate(immediate)
- Acquisition of Core Tissue(immediate)
- Diagnostic Accuracy of EUS-FNA(6 months)
研究者
Mouen Khashab
Assistant Professor of Medicine; Director of Therapeutic Endoscopy
Johns Hopkins University