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临床试验/NCT04741958
NCT04741958已完成不适用

Role of Ultrasound Guided Percutaneous Transthoracic Core Needle Biopsy in Diagnosis of Peripheral Thoracic Tumors

Beni-Suef University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月12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
60
试验地点
2
主要终点
Value of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal).

研究概览

简要总结

The aim of the study was to calculate sensitivity, and accuracy of ultrasound guided percutaneous core needle biopsy in different thoracic tumors (lung, pleural, chest wall and mediastinal).

详细描述

Peripheral intrathoracic shadows are common presentation of different diseases of different origin (chest wall, pleura, pulmonary, and mediastinum), they are increasing in numbers including, peripheral lung cancer, tuberculosis, pneumonia, and atelectasis. [1] Thoracic masses with wall contact represent a frequent pathology that requires complex imaging studies, and often interventional procedures, in order to reach the complete diagnosis. In most cases, after a thoracic lesion is found on a thoracic X-Ray, the next step is to perform a CT and/or a bronchoscopy exam, but pleural and pulmonary lesions often call for additional investigations.

Therefore, transthoracic ultrasonography (US) permits visualization of these lesions, their structural characterization, while offering suggestive elements for their malignant nature and for the differential diagnosis.

Sonography has the capacity to clarify the nature of opaque lesions such as effusions, atelectasis, masses, and consolidations. Transthoracic ultrasound has received increased interest from chest Physicians in recent years as it has the advantages of bedside availability, absence of radiation, and guided aspiration of fluid-filled areas and solid tumors.

Furthermore US allows percutaneous guided biopsies with lower risks compared with the radiological guiding methods (fluoroscopy and CT). Trransthoracic US can replace other imaging modalities of the chest and guide a variety of diagnostic and therapeutic procedures. Under real time US guidance, the success rate of transthoracic needle aspiration or biopsy (TNB) significantly increases, whereas the risk of complications is greatly reduced.

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

性别
All
接受健康志愿者

入选标准

  • An acoustic window for the ultrasound beam to penetrate.
  • Patients have platelet count more than 100000 and normal prothrombin time.

排除标准

  • Cardio vascular instability.
  • Arterio venous malformation or aneurysm.
  • Patients with uncontrolled convulsions

结局指标

主要结局

Value of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal).

时间窗: 8week

diagnostic performance of sonar guided true cut needle biopsy in diagnosis in different thoracic tumors (lung, pleural, chest wall and mediastinal) in 60 patients that had radiographic evidence of thoracic mass suspected of malignancy by measure sensitivity, accuracy, and Positive predictive values * True positive result: the tumor is confirmed by a definite histopathologic diagnosis made by Tru-Cut core biopsy * True negative result: case not diagnosed as a tumor by ultrasound Tru-Cut core biopsy \& this finding was confirmed by another modality for biopsy * False negative result was considered to have occurred if the tumor wasn't diagnosed by ultrasound guided biopsy, and the tumor was confirmed using other modalities (CT guided, Thoracoscopic, or surgical biopsy).

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

Maha Fathy

lecturer of chest

Beni-Suef University

研究点 (2)

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