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临床试验/NCT06479798
NCT06479798已完成不适用

Accuracy of Convex Probe EBUS-TBNA Versus FDG-PET/CT Imaging in Diagnosis of Suspected Lung Cancer & Staging of Concurrent Mediastinal Lymphadenopathy at Ain-Shams University Hospitals

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月21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
40
试验地点
1
主要终点
Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT

研究概览

简要总结

Lung cancer is a prevalent cause of cancer-related mortality on a global scale. Appropriate staging of lung cancer is of paramount importance, as it customizes treatment and predicts prognosis. Fludeoxyglucose-18 (FDG) positron emission tomography (PET) combined with low dose contrast computed tomography (CT) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are two diagnostic modalities widely used in the field of staging & diagnosis of lung malignancies, the former depends on image analysis while the later enables real-time sampling of lymph nodes under sonographic guidance with concurrent cytological examination. The present research aims to compare the diagnostic and staging accuracies of (EBUS-TBNA) versus FDG-PET /CT as two diagnostic modalities in patients with suspected lung malignancies. However as a secondary outcome this study aims at monitoring the possible complications arising post EBUS-TBNA procedure.

详细描述

Lung cancer is a prevalent cause of cancer-related mortality on a global scale. Appropriate staging of lung cancer is of paramount importance, as it customizes treatment and predicts prognosis. Fludeoxyglucose-18 (FDG) positron emission tomography (PET) combined with low dose contrast computed tomography (CT) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are two diagnostic modalities widely used in the field of staging & diagnosis of lung malignancies, the former depends on image analysis while the later enables real-time sampling of lymph nodes under sonographic guidance with concurrent cytological examination.

Objective

To compare the diagnostic and staging accuracy of convex probe EBUS-TBNA versus FDG - PET/CT as two diagnostic modalities in diagnosis of suspected lung cancer & staging of concurrent mediastinal lymphadenopathy Patients and Methods: This prospective, interventional cohort research was performed on 40 cases with suspected lung malignancies. All cases were examined via FDG-PET/CT followed by convex probe EBUS-TBNA for diagnosis of suspected lung cancer & staging of concurrent mediastinal lymphadenopathy.

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

  • Patients 18 years old or more.
  • Patients presented with centrally located suspiciously malignant lung masses with or without lymphadenopathy.
  • patients with mediastinal lymphadenopathy only as evident by contrast - enhanced CT scan of the chest.
  • patients with peripheral lung malignancy and mediastinal lymphadenopathy who were referred for MLN staging were also recruited to the research

排除标准

  • All patients who were who were unfit for bronchoscopy as per international guidelines for practice.
  • Cases are diagnosed with stage IV (metastatic) lung cancer.
  • Patients with histopathological diagnosis other than malignancy (as Sarcoidosis, Tuberculosis).
  • patients unfit for FDG-PET G-PET/CT examination (uncontrolled Hyperglycemia, renal impairment).
  • Patients who refused to participate to the study.

结局指标

主要结局

Comparing the diagnostic accuracies of both EBUS TBNA and FDG-PET /CT

时间窗: 2 years

Comparing the diagnostic yield of both modalies as they are considered primary main diagnostic and staging modalities for lung malignancies

Comparing the staging accuracies of both convex probe EBUS-TBNA versus FDG - PET/CT

时间窗: 2 years

Accurate staging of lung malignancies is considered crucial in determining the prognosis and specifying the treatment plan.

次要结局

  • Determine the complications(2 years)

研究者

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

Fatma Alzahraa

Assistant lecturer of pulmonology

Ain Shams University

研究点 (1)

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