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Not yet recruitingNCT07419191Updated Feb 18, 2026

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

An observational study in Mediastinal ( Chest) Masses and Gastrointestinal Subepithelial Tumors, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Mediastinal ( Chest) Masses
  • Gastrointestinal Subepithelial Tumors
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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 .

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

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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
35 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    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

    Time frame: At time of diagnostic procedure and after histopathological confirmation (within 2 weeks)

Secondary outcomes

  1. Diagnostic accuracy of endoscopic ultrasound elastography for differentiating benign from malignant mediastinal and gastrointestinal subepithelial lesions

    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.

    Time frame: During diagnostic procedure and after histopathological confirmation (within 2 weeks)

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Study locations

1 site
  • Faculty of Medicine
    Asyut, Asyut Governorate 10001, Egypt
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References and documents

Publications

  • Liu T, Al-Kzayer LFY, Xie X, Fan H, Sarsam SN, Nakazawa Y, Chen L. Mediastinal lesions across the age spectrum: a clinicopathological comparison between pediatric and adult patients. Oncotarget. 2017 Apr 18;8(35):59845-59853. doi: 10.18632/oncotarget.17201. eCollection 2017 Aug 29. PubMed 28938687 ↗
  • Verma A, Jeon K, Koh WJ, Suh GY, Chung MP, Kim H, Kwon OJ, Um SW. Endobronchial ultrasound-guided transbronchial needle aspiration for the diagnosis of central lung parenchymal lesions. Yonsei Med J. 2013 May 1;54(3):672-8. doi: 10.3349/ymj.2013.54.3.672. PubMed 23549813 ↗
  • Varanese M, Spadaccini M, Facciorusso A, Franchellucci G, Colombo M, Andreozzi M, Ramai D, Massimi D, De Sire R, Alfarone L, Capogreco A, Maselli R, Hassan C, Fugazza A, Repici A, Carrara S. Endoscopic Ultrasound and Gastric Sub-Epithelial Lesions: Ultrasonographic Features, Tissue Acquisition Strategies, and Therapeutic Management. Medicina (Kaunas). 2024 Oct 15;60(10):1695. doi: 10.3390/medicina60101695. PubMed 39459482 ↗
  • Takeda S, Miyoshi S, Akashi A, Ohta M, Minami M, Okumura M, Masaoka A, Matsuda H. Clinical spectrum of primary mediastinal tumors: a comparison of adult and pediatric populations at a single Japanese institution. J Surg Oncol. 2003 May;83(1):24-30. doi: 10.1002/jso.10231. PubMed 12722093 ↗
  • Schofield PF, Hulton NR, Baildam AD. Is it acute cholecystitis? Ann R Coll Surg Engl. 1986 Jan;68(1):14-6. PubMed 3511830 ↗
  • Lardinois D, Weder W, Hany TF, Kamel EM, Korom S, Seifert B, von Schulthess GK, Steinert HC. Staging of non-small-cell lung cancer with integrated positron-emission tomography and computed tomography. N Engl J Med. 2003 Jun 19;348(25):2500-7. doi: 10.1056/NEJMoa022136. PubMed 12815135 ↗
  • Detterbeck FC, Lewis SZ, Diekemper R, Addrizzo-Harris D, Alberts WM. Executive Summary: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):7S-37S. doi: 10.1378/chest.12-2377. No abstract available. PubMed 23649434 ↗
  • Carder C, Fielding P, Roberts A, Foley K. Discordant nodal staging identifies intermediate-risk group for overall survival in patients with cT3 oesophageal adenocarcinoma. Eur Radiol. 2020 Jun;30(6):3429-3437. doi: 10.1007/s00330-019-06642-6. Epub 2020 Feb 13. PubMed 32055952 ↗
  • Annema JT, Versteegh MI, Veselic M, Welker L, Mauad T, Sont JK, Willems LN, Rabe KF. Endoscopic ultrasound added to mediastinoscopy for preoperative staging of patients with lung cancer. JAMA. 2005 Aug 24;294(8):931-6. doi: 10.1001/jama.294.8.931. PubMed 16118383 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07419191
Lead sponsor
Assiut University
Responsible party
Abanoub Ayoub Melk (assistant lecturer, Assiut University) — Principal investigator
First posted
Feb 18, 2026
Start date
Feb 8, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Feb 18, 2026

Study contacts

Abanoub Ayoub Melk, assistant lecturer
Contact
abanoub_ayoub@yahoo.com
01228261560
Madiha Mohamed El Attar, professor
study director · Assiut University
Haidi KaramAllah Ramadan, Professor
study director · Assiut University
Mohamed Abdelghani Soliman, lecturer
principal investigator · Assiut University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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