A Randomized Trial Comparing a 19-gauge EUS Fine-needle Aspiration Device With a 20-gauge Fine-needle Biopsy Device for the Diagnosis of Autoimmune Pancreatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy (compared to the gold standard diagnosis)
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 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.
详细描述
Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose autoimmune pancreatitis (AIP) and exclude malignancy. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Previous studies suggest 19-gauge fine needle aspiration (FNA) needle provides a reliable specimen for diagnosis of AIP. However 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, the superiority of histology over cytology in EUS-guided tissue sampling for diagnosis of AIP has not been proven yet. In this study, we aim to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 19G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device for the diagnosis of autoimmune pancreatitis.
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 clinical suspicion of AIP
- •Age > 18 years
- •Written informed consent
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
- •Previous inclusion in the current study
- •Pregnancy
结局指标
主要结局
Diagnostic accuracy (compared to the gold standard diagnosis)
时间窗: 24 months
Gold standard diagnosis is defined as: 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 12 months
次要结局
- Quality of the tissue sample(within 2 weeks after the EUS procedure and after 24 months)
- Diagnostic yield of the first needle pass(within 2 weeks after the EUS procedure and after 24 months)
- Adverse events(first 24 hours until - 24 months after procedure)
- Technical success(24 months)
- Quantity of the tissue sample(within 2 weeks after the EUS procedure and after 24 months)