A Multicenter Prospective Clinical Study of Wet-suction Technique and Standard Negative Pressure Technique in EUS-FNB for the Diagnosis of Pancreatic Solid Mass
试验速览
- 阶段
- 不适用
- 入组人数
- 296
- 主要终点
- diagnostic sensitivity of WS technique and SNP technique by EUS-FNB
研究概览
简要总结
The purpose of this study is to compare the diagnosis accuracy between of wet suction (WS) technique and standard negative pressure (SNP) technique in EUS-FNB by 22G EUS Procore fine needle biopsy（FNB）device for solid pancreatic lesions.
详细描述
This is a multi-center, single-blind, randomized, controlled trial. two hundred and ninety six patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will be randomly assigned to two groups. For group A which will be used with 22G EUS Procore fine needle biopsy device, the pass sequence is WS-SNP-WS-SNP technique. For group B with 22G EUS Procore fine needle biopsy device, the pass sequence is SNP-WS-SNP-WS. All procedures will be performed by experienced echo-endoscopists, and the patients and assessors (cytologists and pathologists) will be blinded during the entire study. The primary outcome measure is the diagnosis yield. Secondary outcome measures are specimen quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •informed consent
- •Subjects over 18 years old
- •Imaging examination (ultrasound, CT or MRI) diagnosed or suspected solid pancreatic mass more than 1cm
排除标准
- •Unable or refused to sign informed consent
- •suspended anticoagulant/antiplatelet therapy
- •Being pregnant or breastfeeding
- •Cystic lesions of the pancreas
- •coagulation disorders (PLT <50×103/ L, INR > 1.5)
- •A history of mental illness
- •other medical conditions that are not suitable for FNB puncture
结局指标
主要结局
diagnostic sensitivity of WS technique and SNP technique by EUS-FNB
时间窗: 6 month
Sensitivity will be calculated as the probability of actually having pancreatic diasease and being diagnosed by WS technique during EUS-FNB
diagnostic specificity of WS technique and SNP technique by EUS-FNB
时间窗: 6 month
specificity will be calculated as the probability of actually not having the pancreatic disease and being diagnosed as being free of the disease by WS or SNP technique during EUS-FNB
次要结局
- Sample adequacy of WS technique and SNP technique by EUS-FNB(6 month)
- Cell density of WS technique and SNP technique by EUS-FNB(6 month)
研究者
duowu zou
prof. and director
Ruijin Hospital