A Multicenter Randomized Trial, Comparing a 25G EUS Fine Needle Aspiration (FNA) Device With a 20G EUS ProCore Fine Needle Biopsy (FNB) Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 615
- 试验地点
- 18
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.
详细描述
Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Fine needle aspiration (FNA) provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, FNB needles are stiffer and more difficult to handle, which can complicate tissue acquisition. In addition, the superiority of histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance, tissue, obtained by FNA and processed with the new cell-block technique, may equal the diagnostic yield of histological tissue cores.
A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an adequate cytological specimen. In this study, we aim to compare the properties and merits of a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA device.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for EUS-guided tissue acquisition because of a (I) pancreatic mass lesion or (II) lymph node
- •Age > 18 years
- •Written informed consent
- •Lesion can be visualized with EUS and is ≥1 cm in size
排除标准
- •Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
- •Use of anticoagulants that cannot be discontinued in order to guarantee an INR below 1.5
- •Purely cystic lesions
- •Previous inclusion in the current study
- •Pregnancy
结局指标
主要结局
Diagnostic Accuracy
时间窗: 27 months
Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis Gold standard diagnosis is defined as; 1. in operated patients; based on the surgical resection specimen 2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months
次要结局
- On-site Pathological Evaluation Performed(27 months)
- Presence of Vital Target Cells Per Case, Per Needle Type(after 27 months)
- Number of Patients With Adverse Events Per Needle Type(27 months after procedure)
- Number of Participants in Whom Target Lesion Was Sampled(1 day)
- Diagnostic Yield of the First Needle Pass(after 27 months)