Randomized Controlled Trial of Endoscopic Ultrasound Guided Fine Needle Aspiration of Solid Lesions With and Without a Stylet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Compare Adequacy of Diagnoses in Passes With and Without a Stylet
研究概览
简要总结
The purpose of this study is to determine that there is no difference in final diagnosis of FNA specimens without a stylet, compared to using a stylet, when examined by a skilled cytopathologist.
详细描述
Endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) is a highly accurate method for cytologic diagnosis of malignancy and is routinely performed to diagnose and stage pancreatobiliary, esophageal, gastric, rectal malignancies and subepithelial gastrointestinal lesions. There are variations in EUS-FNA technique including the use of suction, the area of the lesion to target (center versus periphery), gauge of needle, and use of a stylet.
The stylet is a metal wire which is included in the needle assembly. The use of a stylet is used purely for mechanical purposes, not for the protection or safety of the patients. It is thought that the stylet prevents the needle from becoming clogged with gastrointestinal epithelial cells or mucus. To our knowledge, comparing the diagnostic accuracy of EUS-FNA with a stylet to the accuracy without a stylet has not been studied.
The optimal technique for EUS-FNA has not been established. The reported accuracy rate of EUS-FNA (which contains heterogeneous sampling techniques, including with and without a stylet) is 71-98% for pancreatic masses, 90% for lymph nodes, and 67-92% for submucosal gastrointestinal lesions. Typically, FNA is performed with or without a stylet using a 22 gauge or 25 gauge needle with similar diagnostic accuracy.
When the target lesion is identified, the needle is advanced through the gastrointestinal wall into the lesion under ultrasound guidance. If a stylet is being used, it is removed at this point. A 10 cc syringe under suction is then placed on the end of the needle assembly and the needle is moved back and forth within the lesion to gather cells. The assembly is then removed and the needle contents are expelled onto slides and into preservative media. The stylet is then reinserted and the needle assembly is advanced through the scope for another pass. In the absence of on-site cytopathology, 7 passes with or without a stylet of a solid lesion and 5 passes of lymph nodes with or without a stylet are recommended to achieve high diagnostic accuracy.
EUS-FNA is time consuming, mainly because the stylet needs to be carefully reinserted through the needle prior to each pass. Theoretically, the use of a stylet prevents clogging of the needle with gastrointestinal epithelial cells and mucus which can affect the adequacy of the specimen. However, there are no data to support this. As such there is a variation in practice patterns, with some endosonographers who routinely use a stylet and those that do not. Additionally, those who perform percutaneous FNA frequently do so using needles that do not have a stylet. A recent study suggests that the use of a stylet improves diagnostic accuracy in percutaneous FNA of thyroid lesions. To our knowledge, there have been no studies assessing the use of a stylet on tissue adequacy in EUS-guided FNA.
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
- 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
- 否
入选标准
- •patients referred to the Washington University Interventional Endoscopy Division for EUS-guided FNA of a solid lesion (e.g. pancreatic mass, gastric wall mass, or lymphadenopathy)
排除标准
- •Patients <18 years of age
- •patients who cannot provide independent informed consent (i.e. patients with dementia or with a health care proxy)
- •pregnant women (as determined by pregnancy test given as part of standard of care)
- •prisoners
结局指标
主要结局
Compare Adequacy of Diagnoses in Passes With and Without a Stylet
时间窗: At the time of EUS-FNA procedure (Day 1)
The number of passes was determined by the lesion site and mirrored clinical practice (6 passes for pancreatic/other lesions and 4 passes for lymph nodes). The order of these passes was determined by a preprinted randomization sequence kept in an opaque sealed envelope that was opened by the research coordinator or EUS technologist after enrollment. Each participant had an equal number of passes with stylet and without stylet. There was no communication between the endosonographer and the cytopathologist regarding the adequacy of the specimen or diagnosis until all passes had been completed. The on-site evaluation of smears was performed to assess cellular adequacy and to assess the need for any additional passes. Additional passes were made at the discretion of the endosonographer as clinically indicated but were not included in the final analysis. The cytology slides were evaluated by 3 experienced cytopathologists who were all blinded to the stylet status of the passes.
次要结局
- Adequacy of Specimen(At the time of EUS-FNA procedure (Day 1))
- Contamination(At the time of EUS-FNA procedure (Day 1))
- Amount of Blood(At the time of EUS-FNA procedure (Day 1))
- Degree of Cellularity(At the time of EUS-FNA procedure (Day 1))