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临床试验/NCT03391557
NCT03391557Unknown不适用

Significance of Endoscopic Ultrasonography Guided Transbronchial Lymph Node Biopsy (TBNA) and Ultrasound Elastography in Lymph Node

Fangsurong0 个研究点目标入组 42 人开始时间: 2016年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
42
主要终点
The echo characteristic of the B-mode ultrasound of lymph nodes.

研究概览

简要总结

Background and Objectives: Elastography can reflect the difference of tissue hardness, which helps to identify the difference of hardness between benign and malignant tissues. The aim of this study was to evaluate the value of endobronchial ultrasound elastography in the differential diagnosis of benign and malignant intrathoracic lymph nodes. Materials and Methods: A total of 42 patients with intrathoracic lymphadenopathy required for EBUS-TBNA examination were prospectively enrolled. Firstly, All patients were evaluated by enhanced chest CT examination,the EBUS B-mode ultrasound and EBUS-guided elastography before EBUS-TBNA.Then, the investigators evaluated every lymph node by describing the characteristics of the CT image (Short diameter, texture, shape, boundary ,mean CT value), B-mode ultrasound (short diameter, echo characteristic, shape, boundary) and elastography (image type, grading score, strain rate, blue area ratio). Finally, the pathological results were used as the gold standard. the investigators compare the characteristics of the 3 evaluating methods alone and in combination between benign and malignant lymph nodes.

详细描述

Introduction Elastography was first proposed by Ophir of Texas State University in the United States in 1991 ,which can objectively reflect the elastic information of the tissue through the deformation of the external force. Then, the elastic information is converted to RGB (red,green,blue) mode image, where hard tissue is shown in blue, medium tissue in green and soft tissue in red, overlaid on the B-mode image. Different image colors reflect the difference of tissue hardness, and then help identify the difference between benign and malignant tissue hardness. UE has become a hot spot in medical ultrasound imaging shortly after it was proposed. Now UE is widely used in the diagnosis of diseases in the breast, thyroid, prostate and other related tissues. The common clinical UE includes quasi-static elasiticity imaging, acoustic radiation force pulse (ARFI) and shear wave elastography (SWE).

Lung cancer is one of the most common malignancies with high morbidity and mortality,the 5-year survival rate being only 16%. Lymphatic metastasis, the most common mode of metastasis, is of great significance for staging of lung cancer. Therefore, the correct diagnosis of benign and malignant intrathoracic lymph nodes becomes the key to definite diagnosis and accurate treatment. EBUS-TBNA has shown its certain diagnostic value in lung cancer, lymphoma, sarcoidosis and lymph node tuberculosis. However, researches related to real-time endobronchial UE (EBUS-RTE) are scarce, EBUS-RTE combined with EBUS B-mode ultrasound and enhanced CT is even fewer.

This study aimed to evaluate the value of endobronchial UE in differentiating benign and malignant intrathoracic lymph nodes qualitatively and quantitatively, and the combined features were evaluated as well. Here we show that endobronchial UE has significant value in the differential diagnosis of benign and malignant intrathoracic lymph nodes.

Materials and Methods Patients Patients undergoing EBUS-TBNA examination in the Department of Respiratory Diseases, Nanjing Hospital Affiliated to Nanjing Medical University from June 2016 to April 2017 were recruited in this study. All patients were evaluated by chest enhanced CT and/or 18-FDG PET-CT. Those who had enlarged intrathoracic lymph nodes(≥1cm) and/or 18-FDG high uptake (SUV Max > 2.5) without bleeding tendency, abnormal coagulation function and serious cardiac dysfunction were finally selected. The study was approved by the Ethics Committee of Nanjing Hospital (YL 20160713-020) and supported by Nanjing Science and Technology Commission (201505002). All the patients gave written informed consent.

EBUS B-Mode ultrasound The patients were sedated by local anesthesia (lidocaine, China Otsuka Pharmaceutical Incorporated Company) and conscious sedation (midazolam, Jiangsu Nhwa Pharmaceutical incorporated company; fentanyl, Yichang Humanwell Pharmaceutical Incorporated Company; and propyl chloride, Xi'an Libang Pharmacertical Company) .The patients received an ultrasonic bronchoscopy (the Olympus 290 electronic bronchoscopy system of Japanese Olympus Company) from the mouth, the glottis, through the trachea. The locations of the lymph nodes were initially determined according to preoperative imaging examination. The B-mode ultrasound was started and the image focus and depth of observation was adjusted after the ultrasonic water sac was filled, so that the whole target lymph nodes and the surrounding normal tissues were clearly displayed on the screen. the investigators observed multi sections, selected the largest layer of the target lymph node, and retained pictures.The ultrasound image characteristics were independently recorded by three skilled respiratory physicians. The results were discussed and judged until consensus was reached.

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
27 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have enlarged intrathoracic lymph nodes(≥1cm) evaluated by chest enhanced CT and/or 18-FDG high uptake (SUV Max > 2.5) evaluated by 18-FDG PET-CT.
  • Patients who are willing to undergo electronic bronchoscopy and agreed to take TBNA and EBUS-TBNA for pathology.

排除标准

  • There is a contraindication of electronic bronchoscopy: activity of hemoptysis, hypertension and arrhythmia, recent myocardial infarction or unstable angina pectoris attacks, serious heart and lung dysfunction, bleeding tendency which cannot be corrected, serious obstruction of superior vena cava syndrome, suspected aortic aneurysm, multiple pulmonary bullous,the body condition is extremely exhaustion, the pregnant or lactation period women, the infected wound deferred, uncontrollable mental illness.
  • Patients who are not willing to accept electronic bronchoscopy.

研究组 & 干预措施

Patients with the UE examination

Experimental

Patients with enlarged intrathoracic lymph nodes(≥1cm) and/or 18-FDG high uptake (SUV Max > 2.5) without bleeding tendency, abnormal coagulation function and serious cardiac dysfunction were finally selected.

干预措施: UE (Diagnostic Test)

结局指标

主要结局

The echo characteristic of the B-mode ultrasound of lymph nodes.

时间窗: 10 minutes

echo characteristic(hypoechoic or not hypoechoic, homogeneous or not)

次要结局

  • The shape of the B-mode ultrasound of lymph nodes.(10 minutes)
  • The boundary of the B-mode ultrasound of lymph nodes.(10 minutes)
  • The short diameter of the B-mode ultrasound of lymph nodes.(10 minutes)
  • The blue area ratio of the elastography of lymph nodes.(15 minutes)
  • The image type of the elastography of lymph nodes.(10 minutes)
  • The strain ratio of the elastography of lymph nodes.(10 minutes)
  • The grading score of the elastography of lymph nodes.(15 minutes)

研究者

发起方
Fangsurong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fangsurong

Deputy chief physician, master

Nanjing First Hospital, Nanjing Medical University

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