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临床试验/NCT04774679
NCT04774679Unknown不适用

Macroscopic on Cite Evaluation of EUS-FNA Specimen of Gastrointestinal Tumours With Everyday Needle (22g EUS FNA Needle)

Kocaeli University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Correlation of a macroscopically visible fragments in the 22g EUS-FNA needle specimens with final histologic diagnosis

研究概览

简要总结

In order for the diagnosis of digestive system tumors and their appropriate treatment afterward, the type of these tumors should be determined by the pathologist. Pathology doctors need sufficient tissue (a small part of the organ thought to be diseased) to make a diagnosis. Tissue samples were taken from the patients by biopsy procedure. It is examined with microscopes by performing various staining and occasionally it is reported that sufficient tissue cannot be provided to make a diagnosis. In this case, patients may be subjected to repeated biopsy procedures. The aim of this study is to investigate whether the biopsy material obtained by endoscopic ultrasonography (EUS) is sufficient for the diagnosis of the pathology physician with the naked eye. Researchers will try to determine to what extent the physician performing the biopsy procedure can predict whether the tissue he has obtained is sufficient for the pathologist. In this way, researchers think that fewer biopsy repetitions will be needed in the future.

详细描述

This study was designed to improve the acquisition of sufficient tissue (EUS-FNA) with endosonography-assisted fine needle aspiration biopsy, which has been approved and used worldwide for the diagnosis of digestive system diseases. The procedure to be applied in the study is to determine the visible tissue fragments in the sample to be taken after the standard EUS-FNA procedure and to compare it with the diagnosis made by the pathologist. Patients with a tumor detected in the digestive system and referred to the investigation unit for tissue diagnosis will be included in this study. The data obtained in the study will be collected prospectively and will be analyzed retrospectively.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • İn the age range of 18-80 years old
  • Tumour detected withcross-sectional imagined technics in the digestive system

排除标准

  • Refuse to give written informed consent
  • Established bleeding disorder
  • INR>1.5IU plaelet count <100000/dL

结局指标

主要结局

Correlation of a macroscopically visible fragments in the 22g EUS-FNA needle specimens with final histologic diagnosis

时间窗: 1-2 weeks

Macroscopic appearance of the tissue fragments obtained by 22G EUS-FNA needle will be assessed by the endoscopist immediately in the endoscopy room. Endoscopits will decide the tissue acquisition is adequate. The diagnostic yield of the specimens determined by a pathologist will be compared to the endoscopist's first decision according to the macroscopic appearance.

次要结局

  • Area Under the size of the macroscopically visible core size versus histologic core size(1-2 weeks)

研究者

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

Hasan Yılmaz

Assistant Professor

Kocaeli University

研究点 (2)

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