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临床试验/NCT07419191
NCT07419191尚未招募不适用

Role of Endoscopic Ultrasound Elastography in Diagnosis of Gastrointestinal Subepithelial and Mediastinal Lesions

Assiut University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年2月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
35
试验地点
1
主要终点
Diagnostic yield of endoscopic ultrasound in mediastinal lesions and gastrointestinal subepithelial lesions

研究概览

简要总结

The aim of this study is to evaluate the role of endoscopic ultrasound (EUS) in the diagnosis of mediastinal and gastrointestinal subepithelial lesions.

The study also aims to assess the diagnostic accuracy of endoscopic ultrasound (EUS) elastography in differentiating benign from malignant mediastinal and gastrointestinal subepithelial lesions.

详细描述

Endoscopic ultrasound (EUS), which combines ultrasonography and endoscopy, was developed approximately four decades ago and is now an established diagnostic tool for evaluating pancreatic, biliary, and gastrointestinal diseases. Although initially introduced as a purely diagnostic technique, technological advancements have enabled its evolution into a therapeutic modality. These developments have allowed EUS to facilitate cytological and histological diagnoses. In addition, the introduction of advanced imaging technologies, such as EUS elastography and contrast-enhanced harmonic EUS, has further improved real-time tissue characterization during endoscopic examination.

Mediastinal lesions are tumors that originate from, or extend into, the mediastinum. They may also represent metastatic deposits from extrathoracic primary tumors. These lesions encompass a broad histopathologic and radiologic spectrum, ranging from benign cystic and inflammatory conditions to highly aggressive malignant tumors. Mediastinal lesions represent a relatively uncommon but clinically significant group of pathologies, accounting for a small percentage of thoracic masses detected in imaging studies.

Mediastinoscopy remains a well-established diagnostic and staging tool, particularly for mediastinal lymphadenopathy. However, it is an invasive procedure associated with considerable cost, morbidity, and potential procedure-related complications, which may range from minor adverse events to severe and life-threatening complications. Therefore, there is a need for a less invasive yet reliable diagnostic modality. Endoscopic ultrasound offers a safer alternative for evaluating mediastinal pathology and guiding therapeutic decision-making.

For mediastinal lesions, EUS-especially when combined with fine-needle aspiration (FNA) or fine-needle biopsy (FNB)-provides a minimally invasive approach to evaluate and obtain tissue samples from lesions located in the posterior mediastinum. This approach may reduce the need for surgical diagnostic procedures. It is particularly useful for diagnosing lesions of unknown origin, staging mediastinal lymph nodes in lung cancer, and identifying inflammatory or granulomatous diseases such as tuberculosis.

Subepithelial lesions of the gastrointestinal tract present a diagnostic challenge because of their heterogeneous nature and variable clinical presentation. These lesions arise beneath the mucosal layer, originating from the muscularis mucosa, submucosa, or muscularis propria. They are often discovered incidentally during routine endoscopy or radiologic imaging. Although most subepithelial lesions are small and asymptomatic, they may occasionally cause dysphagia, gastrointestinal bleeding, or compressive symptoms. Their biological behavior ranges from benign and indolent to malignant and potentially aggressive neoplasms, such as gastrointestinal stromal tumors and neuroendocrine tumors.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: Adults ≥ 12 years.
  • Clinical indication: Patients referred for diagnostic EUS of a 1_mediastinal mass or mediastinal lymphadenopathy detected on prior imaging (CT/MRI) .
  • 2- subepithelial lesions lesion detected by endoscopy .
  • Lesion accessibility: Lesion judged by the endosonographer to be accessible to EUS imaging and elastography and amenable to EUS-guided sampling

排除标准

  • • patient Refusal or inability to provide informed consent
  • Uncorrectable coagulation disorder
  • Presence of contraindicating endoscopy/sedation
  • Lesion inaccessible to EUS or elastography (e.g., too far from the esophagus/airway to obtain reliable elastography or visualization) as judged by the performing endosonographer.

结局指标

主要结局

Diagnostic yield of endoscopic ultrasound in mediastinal lesions and gastrointestinal subepithelial lesions

时间窗: At time of diagnostic procedure and after histopathological confirmation (within 2 weeks)

Diagnostic yield will be defined as the proportion of participants in whom endoscopic ultrasound provides a definitive diagnosis confirmed by histopathological examination obtained through fine-needle aspiration, fine-needle biopsy, or surgical specimens

次要结局

  • Diagnostic accuracy of endoscopic ultrasound elastography for differentiating benign from malignant mediastinal and gastrointestinal subepithelial lesions(During diagnostic procedure and after histopathological confirmation (within 2 weeks))

研究者

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

Abanoub Ayoub Melk

assistant lecturer

Assiut University

研究点 (1)

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