The Cellularity Yield of Three Different 22-gauge Endoscopic Ultrasound Fine Needle Aspiration Needles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- 1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles
研究概览
简要总结
Obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a flexible tube with a camera and small ultrasound machine at its end )requires the use of a needle for taking the sample from the lesion or what we call "Fine needle aspiration (FNA)". Currently, FNA is done by three commercially available needles. These needles are used routinely in our institution for FNA. The data regarding the safety and the successfulness of any of these needles are lacking. We sought to compare all three commercially available needles in a prospective manner.
详细描述
The following are being done only for research purposes; prior to performing the FNA, The patient will be randomized to one of the three commercially available FNA needles. At this time, all needles are considered equivalent and there is no medical necessity to pick one over another. The sample obtained by the needle will be assigned a quality score based on certain parameters of the sample such as the abundance of diagnostic cells and the presence of blood. We are going to collect certain information about your procedure such as the complications of the procedure, number of needle passes and final diagnosis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-88) who are undergoing EUS FNA of pancreatic or peripancreatic lesions
- •Adult patients (18-88) who are undergoing EUS FNA of submucosal masses in the esophagus, stomach, duodenum or rectum
- •Adult patients (18-88) who are undergoing EUS FNA of mediastinal masses.
- •Adult patients (18-88) who are undergoing EUS FNA of enlarged lymph nodes
排除标准
- •Patients younger than 18 yrs old or older than 88 yrs.
- •Pregnant patients
结局指标
主要结局
1. Compare the overall diagnostic accuracy of the three commercially available 22 gauge EUS needles
时间窗: 2 days after the procedure
Cellularity score will be assessed by the cytopathologist using the scoring system from 0 to 10 score. This scoring system evaluate the amount of blood, malignant cells and contaminant cells. The system is a modified form Mair et al study. " Mair S, Dunbar F, Becker PJ, Du Plessis W. Fine needle cytology--is aspiration suction necessary? A study of 100 masses in various sites. Acta cytologica 1989;33:809-13."
次要结局
- Compare the number of FNA needles passes required to reach the diagnosis.(During the procedure ( 30 -45 minutes))
- Compare the complication rate between the three commercially available 22 gauge EUS needles.(up to 1 month after the procedure)
- Compare the technical success of the three commercially available 22 gauge EUS needles(During the procedure ( 30-45 minutes))
研究者
Mohamed O Othman
Assistant Professor
Texas Tech University Health Sciences Center, El Paso