Yield Rate for Procurement the Histologic Core With Endoscopic Ultrasound-guided Fine Needle Biopsy With 20-gauge Ultrasound Biopsy Needles for Solid Pancreatic Masses: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Procurement of the histologic core
研究概览
简要总结
To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
详细描述
Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis.
Regarding the diagnosis of pancreatic cancer, proper tool with high diagnostic yield is very important. The investigators investigated the technical feasibility and diagnostic yield of recent-developed new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.
The investigators applied the 20-gauge procore needle for EUS-guided fine needle biopsy in the diagnosis of pancreatic solid mass. A total of 30 patients will be enrolled for the present pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are at least 20 years of age
- •patients who require endoscopic ultrasound-guided fine needle aspiration cytology or biopsy because of pancreatic or peripancreatic solid mass.
排除标准
- •Cystic pancreatic mass in imaging tests such as CT or MRI or US
- •haemodynamically unstable patients
- •severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3])
- •patients unable to quit anticoagulant/anti-platelet therapy
- •pregnancy
研究组 & 干预措施
Intervention group
EUS-FNB using 20-gauge procore needle
干预措施: 20-gauge ProCore FNB needle (Device)
结局指标
主要结局
Procurement of the histologic core
时间窗: 7 days after the procedure
The sample quality is evaluated as optimal for histological evaluation; the presence of optimal histological core including recognizable structures
Diagnostic accuracy
时间窗: 7 days after the procedure
\[Standard diagnosis\] * In operated patients; based on the surgical resection specimen * In non-operated patients; based on the conclusions of the diagnostic work-up and confirmed by a compatible clinical disease course
次要结局
- Technical success(7 days after the procedure)