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临床试验/NCT01995474
NCT01995474已完成不适用

Eliminating the Residual Negative Pressure in the EUS-FNA Needle Before Withdrawal Enhances the FNA Cytology Yield

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Efficacy of FNA biopsy

研究概览

简要总结

Endoscopic ultrasound and fine needle aspiration are useful tools for the diagnosis and staging of pancreatic cancer. One potential limitation is contamination when needle traverses the gastrointestinal tract under continuous negative pressure. Gastrointestinal tract contamination can lead to misinterpretation of FNA specimens. We propose a technique to eliminate any remaining negative pressure during EUS-FNA and therefore decrease gastrointestinal tract contamination. Our hypothesis is that briefly untwisting the syringe from the biopsy channel after a specimen is obtained eliminates any remaining negative pressure in the FNA needle and therefore reduces GI tract contamination of EUS-FNA specimens, and will lead to improved diagnostic accuracy of this important clinical technique.

详细描述

Endoscopic ultrasound (EUS) has evolved into a minimally invasive diagnostic and staging method. The addition of fine needle aspiration (FNA) increases the accuracy of EUS in the diagnosis and staging of pancreatic malignancies. An ultrasound probe attached to the end of the endoscope allows real-time direct visualization by means of ultrasound transmission. During the FNA process a needle is advanced through the biopsy channel of the endoscope and into the target lesion. In order to obtain a tissue specimen of a suspicious pancreatic lesion, an FNA needle must traverse either the stomach or duodenum to access the pancreatic mass. Once the needle has entered the target lesion a syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen. Negative pressure is released from the syringe and the stop cock is closed to the syringe. However, due to the relatively long length of the needle there is is significant remaining negative pressure at the needle tip. This leads to aspiration of surrounding material including GI mucosal contamination into the needle while removing it from the target lesion.

Contamination of the FNA specimen from gastric or duodenal epithelium can occur with continued negative pressure at the needle tip upon withdrawal of the needle out of the target lesion. While EUS-FNA has a high specificity (96%), sensitivity (87%), and accuracy (94%), gastrointestinal tract contamination can lead to misinterpretation of FNA specimens. Based on clinical experience, we propose a technique to eliminate any remaining negative pressure during EUS-FNA and therefore decreasing gastrointestinal tract contamination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (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

入选标准

  • Age > 18
  • Not pregnant
  • Can give consent
  • Patients with suspicious GI lesions in need of tissue diagnosis by means of EUS/FNA

排除标准

  • Age < 18
  • Cannot give consent
  • EUS not technically possible

结局指标

主要结局

Efficacy of FNA biopsy

时间窗: 1 week

The efficacy of fine needle aspiration is assessed using on site cytopathologists who are blinded with respect to the study ARM. The efficacy of diagnostic yield from samples obtained using the needle-off technique is directly compared to the diagnostic yield of samples obtained using conventional technique.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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