Wet-suction Versus Slow-pull Technique for Endoscopic Ultrasound-guided Fine-needle Biopsy of Solid Lesions: a Multicentric Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Histologic yield
研究概览
简要总结
A randomized cross-over study investigating the impact of two different suction techniques on histological yield and sample quality of specimens collected by endoscopic ultrasound biopsy from solid lesions using histology needles.
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
- Double (Participant, Investigator)
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
- •Solid pancreatic lesions 3 1cm
- •Peri-GI tract lymph nodes 3 1cm
- •Peri-GI tract masses
- •Lesions of the GI wall
- •Signed informed consent
排除标准
- •Pancreatic cystic lesions (more than 50% of the volume)
- •Diameter of lesion ≤ 1 cm
- •Lesion not seen at EUS
- •Pregnancy
- •Coagulopathy (platelet count <50.000/mm3 and/or international normalized ratio >1.5);
- •Severe cardiorespiratory dysfunction precluding endoscopy;
- •Failure to provide informed consent
研究组 & 干预措施
WET-SUCTION
The stylet will be removed and the needle will be pre-flushed with 1-2mL of saline. The lesion will then be punctured, and suction will be applied using a 10-mL pre-vacuum syringe. The sample collected will be pushed into a formalin vial with saline.
干预措施: Endoscopic ultrasound-guided fine-needle biopsy (Procedure)
SLOW-PULL
After puncturing the lesion, the stylet will be slowly and gradually withdrawn for at least 40cm. The sample will be pushed into formalin using the stylet.
干预措施: Endoscopic ultrasound-guided fine-needle biopsy (Procedure)
结局指标
主要结局
Histologic yield
时间窗: 6 months
The rate of samples containing a tissue "core" (yes/no) for histological evaluation, defined as an intact piece of tissue of at least 550 μ
次要结局
- Blood contamination(6 months)
- Tumor fraction(6 months)
- Tissue integrity(6 months)
- Diagnostic accuracy(6 months)
研究者
Stefano Francesco Crinò, MD
Principal Investigator
Azienda Ospedaliera Universitaria Integrata Verona