Evaluation of a Newly Designed 22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination in Patients With Solid Lesions: A Prospective Two Centers Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- - Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
研究概览
简要总结
To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.
详细描述
The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this new needle are the possibility of increasing the chance of retrieving tissue specimens for histological examination, with the possibility of increasing the diagnostic accuracy of the procedure saving the need and the cost deriving from on-site cytopathology examination. This may reduce the need to repeat EUS procedures or other more invasive sampling procedures, including surgery.
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
- None
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 and less than
- •Presence of a solid lesion within or adjacent of the gastrointestinal tract. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- •Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- •Informed consent is obtained
排除标准
- •Previous biopsy of the lesion with diagnosis of malignancy
- •Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- •They are unable to understand and/or read the consent form.
研究组 & 干预措施
Adominal neoplasms patients
Patients in whom EUS-FNTA is performed with a novel type of biopsy neede.
干预措施: Fine Needle Tissue Acquisition (Other)
结局指标
主要结局
- Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA.
时间窗: intraoperative
diagnostic accuracy
次要结局
- rate of complications(perioperative)
研究者
Guido Costamagna
professor
Catholic University of the Sacred Heart