Official Title: Dry Suction Technique Versus Wet Suction Technique of Endoscopic Ultrasound-Guided Fine-needle Biopsy for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- diagnostic accuracy
研究概览
简要总结
Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.
详细描述
The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years;
- •Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
- •Plan to receive EUS-FNB.
- •Able to obtained informed consent.
排除标准
- •Had expected difficulty of endoscope insertion
- •That no lesion in the pancreas is identified by EUS
- •Use of anticoagulants/antiplatelet drugs that cannot be discontinued.
- •Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time >1.5 or a platelet count <50,000 cells/mL
- •Other medical conditions that render the patient an unsuitable candidate for EUS-FNB.
- •Vulnerable groups such as pregnant women or patients with mental disorders;
- •Patients unable to understand and/or read the consent form.
结局指标
主要结局
diagnostic accuracy
时间窗: 12 months
compare the rate of diagnostic accuracy of EUS- FNB using the two different suction techniques (dry suction and wet suction) in patients with solid pancreatic lesions.
次要结局
- Samples tissue integrity(12 months)
- Samples cellularity(12 months)
- Percentage of procedure related adverse events [Safety](24 months)
- the diagnostic in relation to the number of needle passes(12 months)
- Time (minutes) of the procedures with dry suction and wet suction(12 months)