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临床试验/NCT04561999
NCT04561999Unknown不适用

Value of Ultrasound Elastography in Characterization of Superficial Lymphadenopathy

Assiut University0 个研究点目标入组 70 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
主要终点
To evaluate the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes by its additional information over the classic gray scale and color Doppler ultrasound.

研究概览

简要总结

Evaluation of the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes and its additional information over the classic gray scale and color Doppler ultrasound.

详细描述

Lymph nodes are part of the body immune system which are located throughout the body including head and neck, armpit, and groin.

Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes.

The differentiation of malignant from benign lymph nodes is essential because it predicts the patient prognosis and help in the decision making regarding the management plan.

On ultrasound, gray scale sonography helps to evaluate nodal morphology, whilst color doppler is used to assess vascular pattern. The qualitative criteria for malignancy were heterogenous hypoechoic cortex, irregular margins, lack of hyperechoic fatty hilum and abnormal blood vessels penetrating the lymph nodes capsule.The avascular or hilar patterns were defined as LNs with normal vascularity pattern, and the peripheral or mixed (peripheral and hilar) pattern as LNs with abnormal vascularity pattern. On B-mode and color doppler ultrasound, there is no specific criteria for differentiating metastatic lymph nodes from reactive lymph nodes with 100% accuracy.

Fine-needle aspiration biopsy is the reference standard for differentiating metastatic lymph nodes from reactive lymph nodes. However, restrictions of fine-needle aspiration biopsy are that it is an invasive procedure, and it is not possible to perform for lymph nodes smaller than 5 mm.Therefore, a simple, reliable, and non-invasive imaging modality for differentiating malignant lymph nodes is required.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients presented with enlarged lymph nodes by clinical examination.

排除标准

  • Patients who previously receive any medical treatment or chemo or radiotherapy.
  • Patients who previously underwent fine needle aspiration cytology or biopsy.

结局指标

主要结局

To evaluate the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes by its additional information over the classic gray scale and color Doppler ultrasound.

时间窗: one year

Shear wave elastography (SWE): measures a different type of waves that is also produced when tissues are mechanically stimulated. Shear wave elastography is also a quantitative method of analysis for elasticity images using shear wave speed (m/s).

次要结局

未报告次要终点

研究者

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

Nermin Gamal Eldin Ahmed Abdel Sattar

Principal investigator

Assiut University

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