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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07419191
Enrollment
35
Registered
2026-02-18
Start date
2026-02-08
Completion date
2027-12-30
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Subepithelial Tumors, Mediastinal ( Chest) Masses

Brief summary

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.

Detailed description

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. Endoscopic ultrasound is currently considered one of the most effective imaging techniques for characterizing subepithelial lesions. It provides detailed information regarding the layer of origin, size, echogenicity, vascularity, and relationship to adjacent structures. Endoscopic ultrasound-guided fine-needle aspiration or fine-needle biopsy enables cytologic or histologic confirmation of the lesion's nature. In addition, EUS elastography enhances the diagnostic capability of conventional EUS by providing real-time assessment of tissue stiffness, which may help differentiate benign from malignant lesions. EUS elastography can be performed using strain elastography or shear wave elastography techniques. Strain elastography evaluates tissue deformation in response to external compression, whereas shear wave elastography measures shear wave velocity as an indirect indicator of tissue stiffness. Although most research has focused on pancreatic masses, emerging evidence suggests potential applications in mediastinal lymph nodes and gastrointestinal subepithelial lesions.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* • 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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic yield of endoscopic ultrasound in mediastinal lesions and gastrointestinal subepithelial lesionsAt 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

Secondary

MeasureTime frameDescription
Diagnostic accuracy of endoscopic ultrasound elastography for differentiating benign from malignant mediastinal and gastrointestinal subepithelial lesionsDuring diagnostic procedure and after histopathological confirmation (within 2 weeks)Diagnostic performance will be determined by comparing elastography findings with histopathological results obtained through fine-needle aspiration, fine-needle biopsy, or surgical specimens. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy will be calculated.

Countries

Egypt

Contacts

CONTACTAbanoub Ayoub Melk, assistant lecturer
abanoub_ayoub@yahoo.com01228261560
STUDY_DIRECTORMadiha Mohamed El Attar, professor

Assiut University

STUDY_DIRECTORHaidi KaramAllah Ramadan, Professor

Assiut University

PRINCIPAL_INVESTIGATORMohamed Abdelghani Soliman, lecturer

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026