EUS-guided Fine Needle Tissue Acquisition Using a Newly Developed Nitinol Ultra Flex 19 Gauge Needle for Transduodenal Lesions: a Multicenter Prospective Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 6
- 主要终点
- Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion
研究概览
简要总结
This study evaluates the feasibility, safety and accuracy of a 19 gauge (19G) needle in nitinol in the performance of endoscopic ultrasound (EUS) guided transduodenal biopsy for the acquisition of samples for histologic analysis. Patients with lesions that can be approached only from the duodenum will be prospectively enrolled.
详细描述
A 19 gauge needle in nitinol (Flex needle) has been recently become available for EUS guided procedure.
The use of nitinol should guarantee a better needle flexibility with a theoretical advantage on the use of this needle for lesions that need to be sampled through the duodenum. Moreover, samples for histologic examination seems to be easy to interpret than cytologic ones allowing evaluate of the overall architecture of the tissue, better performance of immunohistochemical staining, and may be of additional value to perform tissue profiling that in the future will be very important to guide individualized therapies
The existing data on the performance of the Flex needle for EUS-guided transduodenal biopsy are coming form a single study performed in one single center. Thus, the reproducibility of these results is unknown and multicenter prospective studies are warranted to answer this important question.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Age greater than 18 and less than
- •B. Presence of a solid lesion of the gastrointestinal tract adjacent to the duodenum with no previous tissue diagnosis.
- •C. 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.
- •D. Informed consent is obtained.
排除标准
- •A. 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.
- •B. Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum.
- •C. They are unable to understand and/or read the consent form.
研究组 & 干预措施
patients with solid lesions
Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)
干预措施: Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA) (Device)
结局指标
主要结局
Capability of Performing EUS-FNTA Through the Duodenum by Placing the Target Lesion in the Proper Position With Insertion of the Needle Into the Lesion
时间窗: Intraoperative
Number of patients in which it was possible to place the needle within the target lesion by a transduodenal route divided by the total number of enrolled patients.
次要结局
- Number of Complications Divided Per Total Number of Enrolled Patients(intraoperative and within 3 days after the procedure)
- Number of Histological Samples Judged Adequate Divided by the Total Number of Patients(5 days)
- Number of Correct Diagnosis Divided by the Total Number of Patients(6 months)
研究者
Guido Costamagna
Professor of Surgery
Catholic University of the Sacred Heart