Modified Wet Suction Versus Capillary Techniques for EUS Guided Fine Needle Aspiration and Biopsy of Solid Lesions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Rate of core tissue acquisition adequate for histologic analysis.
研究概览
简要总结
The purpose of the study is to compare two particular techniques of tissue (capillary vs wet-suction techniques) sampling during endoscopic ultrasound guided fine needle aspiration/biopsy (EUS-FNA/FNB) of a solid lesion to determine the diagnostic yield and procedure logistics (e.g. procedure time).
详细描述
All adult patients who are undergoing EUS for solid lesions at Loma Linda University Health gastroenterology lab. These patients will be recruited at the time preceding their endoscopy in the Gastroenterology lab. They will be explained the goals, randomization, and interventions of the study. The collected patient information, as well as the steps to safeguard the information, will be explained.
Patients will be randomly assigned to capillary or wet-suction techniques arms according to computerized randomization program that has already been generated.
All patients will undergo routine EUS under possible moderate sedation or general anesthesia, with FNA/FNB. Cook Pro-core 22 gauge needle will be used for all the procedures. For each lesion undergoing FNA/FNB procedure, a total of 4 passes will be made using the selected technique.
The research aspect differentiates the method of tissue acquisition: modified wet-suction technique versus the "slow pull" capillary technique.
For the modified wet-suction technique:
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 (Participant)
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
- •All adult patients (greater than 18 years of age) who are referred for EUS guided sampling of solid lesions.
排除标准
- •Any patients with contraindication to EUS- fine-needle aspiration/fine-needle biopsy (FNA/B), including those on anti-platelet or on anti-coagulation therapy, or with congenital disorders.
- •Patients with cystic lesions or submucosal lesions will also be excluded.
结局指标
主要结局
Rate of core tissue acquisition adequate for histologic analysis.
时间窗: 4 weeks
次要结局
- Procedure time(4 weeks)
- Diagnostic yield will measure the percentage of tissue acquisition cases that matched up with the final diagnosis.(4 weeks)
- Tissue smear and cell block cellularity will be graded along this scale: Cellularity, graded 0 = no cells, 1 = sparsely cellular, 2 = moderately cellular, and 3 = highly cellular.(4 weeks)
- Tissue smear and cell block will be assessed of blood contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated, with or without blood clots.(4 weeks)
- Tissue smear and cell block will be assessed of insertion tissue contamination with this scale: graded 0 = free of contamination, 1 = contaminated, 2 = highly contaminated.(4 weeks)
- Tissue smear and cell block will be assessed of diagnosis characteristic with this scale: 0 = not adequate, 1 = suspicious for particular etiology, 2 = diagnostic for etiology, e.g. cancer.(4 weeks)
- Cell block will be assessed of presence of any core tissue with intact architecture with this scale: graded 0 = none, 1 = present but marginal adequacy, 2 = present and adequate. Dimensions of the largest core will be noted if possible.(4 weeks)
研究者
Alexander Jahng, MD
Gastroenterology attending
Loma Linda University