Comparing the Diagnostic Efficacy of Different Suction Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy of Pancreatic Solid Lesions Using 25G Procore Needle: a Prospective Randomized Controlled Multicentric Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- specificity of each individual technique
研究概览
简要总结
There are many factors that can affect the diagnostic yield of EUS-FNA, including lesion factors, the endoscoist experience, the needle size, the number of needle passes, and the suction technique. since diagnostic efficacy of different suction techniques for EUS-FNB is still uncertain, thus we decided to compare the diagnostic efficacy of three common methods: the 10 ml standard negative pressure, slow pull and wet suction.
详细描述
the standard suction: after the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.
slow-pull : after the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
wet suction: after removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years,male or female
- •diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
- •lesion diameter larger than 1 cm
- •signed informed consent letter
排除标准
- •pregnant female
- •Pancreatic cystic lesions
- •Anticoagulant/antiplatelet therapy cannot be suspended
- •unable or refuse to provide informed consent
- •Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
- •Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
- •with history of mental disease
- •other medical conditions that are not suitable for EUS-FNB
研究组 & 干预措施
standard suction
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the standard suction technique with 10ml negative pressure
干预措施: standard suction (Diagnostic Test)
slow pull
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique
干预措施: slow pull (Diagnostic Test)
wet suction
This arm will include all the patients that will get an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique
干预措施: wet suction (Diagnostic Test)
结局指标
主要结局
specificity of each individual technique
时间窗: 1 year
The results are compared with the gold standard and calculated the specificity
diagnostic accuracy of each individual technique
时间窗: 1 year
The results are compared with the gold standard and calculated the accuracy
diagnostic sensitivity of each individual technique
时间窗: 1 year
The results are compared with the gold standard and calculated the sensitivity
次要结局
- cellularity(1 year)
- blood contamination(1 year)
- adverse event rate of each individual technique(1 year)
- adequacy of specimens obtained by each individual technique(1 year)
研究者
Zhaoshen Li
chief of the Gastroenterology
Changhai Hospital