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

February 16, 2026 updated by: Abanoub Ayoub Melk, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 10001
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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 .

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield of endoscopic ultrasound in mediastinal lesions and gastrointestinal subepithelial lesions
Time Frame: 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
At time of diagnostic procedure and after histopathological confirmation (within 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of endoscopic ultrasound elastography for differentiating benign from malignant mediastinal and gastrointestinal subepithelial lesions
Time Frame: During 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.
During diagnostic procedure and after histopathological confirmation (within 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Madiha Mohamed El Attar, professor, Assiut University
  • Study Director: Haidi KaramAllah Ramadan, Professor, Assiut University
  • Principal Investigator: Mohamed Abdelghani Soliman, lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 8, 2026

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • EUS in Mediastinal &GI lesions

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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