Comparison of Two Types of Biopsy Needles for Endoscopic Ultrasound-guided Fine Needle Biopsy (EUS-FNB) in Solid Pancreatobiliary Mass Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Comparison of EUS-FNB sensitivity using two types of FNB needles
研究概览
简要总结
EUS-guided tissue acquisition is an established modality to diagnose malignancies of the pancreas and extrahepatic bile ducts. In the recent years fine needle biopsy (FNB) needles have largely replaced fine needle aspiration (FNA) for EUS-guided tissue acquisition. The Acquire FNB needle is a Franseen needle which has three symmetric cutting edges to obtain core tissue specimens. The Trident FNB needle has been recently introduced to the market for EUS-guided tissue acquisition. It has a multi-blade three-prong tip which one of the tips is longer than the other two.
The aim of this study is to prospectively compare these two types of needle in term of diagnostic accuracy, and safety profile.
详细描述
Patients with solid mass lesions in the pancreas or extrahepatic biliary system will be randomly assigned to one of two types of FNB needle. Four passes of FNB will be acquired from the mass lesion in each patient. The primary aim is to compare sensitivity of two types of FNB needle to diagnose malignancy. Also, each pass of FNB needle will be assessed separately by two expert pathologists to determine per-pass sensitivity of two types of FNB needles.
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)
盲法说明
The pathologists who assess the FNB specimens are blinded on the needle type
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
- •Inpatients and outpatients 18 years of age or older with solid mass lesions in the pancreas or extrahepatic biliary system
排除标准
- •Uncorrectable coagulopathy (INR > 1.5)
- •Uncorrectable thrombocytopenia (platelet < 50,000)
- •Decline to participate in the study and sign the informed consent form
- •Cystic lesions.
研究组 & 干预措施
Franseen needle with three symmetric cutting edges
These patients will undergo endoscopic ultrasound-guided fine needle biopsy using the Franseen needle (Acquire FNB needle; Boston Scientific): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation.
干预措施: Fine needle biopsy (Device)
Multi-blade needle with three-prong tip with one tip longer than the other two
These patients will undergo endoscopic ultrasound-guided fine needle biopsy using a multi-blade three-prong tip needle (Trident; Microtech): eight back and forth movements within the lesion will be performed with simultaneous minimal negative pressure provided by withdrawing the needle stylet slowly. Four passes of FNB will be made from each mass lesion and the specimens from each pass will be placed in different containers for cell block preparation and histologic evaluation.
干预措施: Fine needle biopsy (Device)
结局指标
主要结局
Comparison of EUS-FNB sensitivity using two types of FNB needles
时间窗: 6 months
Comparison of EUS-FNB sensitivity using two types of FNB needles
次要结局
- Comparing the adequacy of specimen for each pass in two types of FNB needles(6 months)
- Comparing per-pass sensitivity in two types of FNB needles(6 months)
- Comparing the rate of core tissue acquisition for each pass in two types of FNB needles(6 months)
- Comparing specimen cellularity for each pass in two types of FNB needles(6 months)
- Comparing the score of blood content n for each pass in two types of FNB needles.(6 months)
研究者
Mehdi Mohamadnejad
Associate professor of medicine
University of Tehran