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临床试验/NCT04165018
NCT04165018已完成不适用

Prospective Study FNB, Is It Time To Abandon Cytological Assessment (FACET)

Baylor College of Medicine2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Sensitivity and Specificity using FNB sampling pancreatic mass

研究概览

简要总结

Endoscopic Ultrasound (EUS) is a minimally invasive procedure used by gastroenterologists to examine pancreatic masses and lesions. A fine needle is traversed through an endoscope and used to acquire tissue samples, which are then sent for pathology. The standard approach for diagnosing solid pancreatic lesions has been fine needle aspiration (FNA) (Han et al. 2016). However, the use of FNA comes with its limitations, some of which include multiple needle passes to acquire fluid, the need for on-site cytologists, and decreased diagnostic yield. Fine needle biopsy (FNB) is the latest approach being employed by endosonographers in lieu of FNA. FNB confers several advantages over FNB. First, FNB requires fewer needle passes than FNA to acquire tissue sample for immunohistochemical staining. In addition, FNB provides better tissues samples, greater sensitivity of the tissue core, and thus, improved diagnostic yields (Tian et al. 2018). Finally, FNB is more cost-effective than FNA and relies on pathologists, instead of on-site cytologists, and preserves the tissue core (Tian et al. 2018). The objective of this study is to establish a database of samples placed in formalin for patients who will undergo a fine-needle biopsy (FNB) for pathological evaluation without rapid on site cytological assessment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient is greater than or equal to 18 years of age
  • Patient is referred to EUS-FNB for pancreatic mass lesions

排除标准

  • Patient is younger than 18 years of age
  • Patient refused and/or unable to provide consent
  • Patient is a pregnant woman

结局指标

主要结局

Sensitivity and Specificity using FNB sampling pancreatic mass

时间窗: 2 years

% of core tissue obtained, number of needle passes made, and assessment of any procedure related adverse events

Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle

时间窗: 2 years

次要结局

  • Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Othman, MD

Principal Investigator

Baylor College of Medicine

研究点 (2)

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