Randomized Trial Comparing Fine Needle Biopsy and Fine Needle Aspiration Needles for Endoscopic Ultrasound -Guided Sampling of Solid Pancreatic Masses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- The total area of procured tissue between the FNA and FNB needles
研究概览
简要总结
This is a randomized prospective clinical study comparing a fine needle biopsy device and an aspiration needle.
详细描述
At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G FNA or FNB needle. All patients will undergo sampling of pancreatic masses using both needles but the needle to be used first will be based on randomization. Subsequent passes will be performed by alternate needles and once onsite diagnosis is established using either needle type, more passes will not be performed for onsite diagnostic adequacy. However, a minimum of at least one pass and a maximum of 8 passes will be performed using both needle types. The number of passes needed to achieve diagnostic adequacy using both needles will documented.
Four dedicated passes will then be performed using the initial randomization sequence for cell block. Two passes will be performed using each needle type and the specimen will be preserved in formalin and sent for cell block processing.
If the doctor cannot obtain enough tissue with the study needles, another needle with a different gauge (19 or 25) will be used. This will also be a maximum of 8 passes. Information about the number of needles used, how many passes were performed, any problems with the needles will be collected. If there is not enough tissue available from these passes to establish a diagnosis, the subject will be asked to come back at another time for a repeat procedure.
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 (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
- •Scheduled to undergo EUS
- •Patients with solid pancreatic masses on cross-sectional imaging or with jaundice secondary to biliary obstruction
- •Able and willing to provide written or verbal consent
排除标准
- •Unable to safely undergo EUS for any reason
- •Coagulopathy (Prothrombin time > 18 secs, platelet count < 80,000/ml)
- •Active alcohol or other drug use or significant psychiatric illness
- •Pregnancy
- •Unable or unwilling to provide consent
研究组 & 干预措施
Acquire EUS Biopsy Device
All patients will undergo sampling of pancreatic masses using the Acquire EUS Biopsy Device. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types.
干预措施: Acquire EUS Biopsy Device (Device)
Expect EUS Aspiration Needle
All patients will undergo sampling of pancreatic masses using the Expect EUS Aspiration Needle. Both needles will be used, but the needle to be used first will be based on randomization. A minimum of at least one pass and a maximum of 8 passes will be performed using both needle types
干预措施: Expect EUS Aspiration Needle (Device)
结局指标
主要结局
The total area of procured tissue between the FNA and FNB needles
时间窗: 6 months.
The primary objective of this study is to compare the total area of procured tissue between the FNA and FNB needles in patients undergoing EUS-guided sampling of pancreatic masses. Pancreatic masses sampled using the FNB needle should have a tissue area greater than the FNA needle because of the serrated design of the FNB needle tip. This will be measured using a specialized digital image analysis software. This hypothesis will be tested by comparing the total tissue area, tumor area within the tissue, stroma area within the tissue, tumor vs. stroma ratio and the macroscopic length of the procured tissue measured in millimeters. The total of these measurements will provide information about the area of procured tissue.
次要结局
- Diagnostic adequacy between the FNA and FNB needles(6 months)