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

NCT07419191 | Not Yet Recruiting DMC

• 1 other identifier: EUS in Mediastinal &GI lesions
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediastinal ( Chest) Masses; Gastrointestinal Subepithelial Tumors

Outcome Measures

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

  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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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) .
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, 10001, Egypt

Location

Related Publications (9)

• 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.

  PMID: 28938687 BACKGROUND

• 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.

  PMID: 23549813 RESULT

• 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.

  PMID: 39459482 RESULT

• 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.

  PMID: 12722093 RESULT

• Schofield PF, Hulton NR, Baildam AD. Is it acute cholecystitis? Ann R Coll Surg Engl. 1986 Jan;68(1):14-6.

  PMID: 3511830 RESULT

• 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.

  PMID: 12815135 RESULT

• 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.

  PMID: 23649434 RESULT

• 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.

  PMID: 32055952 RESULT

• 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.

  PMID: 16118383 RESULT

Related Links

• o Yamashita, Y., \& Kitano, M. (2024). Role of contrast-enhanced harmonic endoscopic ultrasonography (EUS) and EUS elastography in pancreatic lesions. Clinical Endoscopy, 57(2), 164-174.

Study Officials

• Madiha Mohamed El Attar, professor

  Assiut University

  STUDY DIRECTOR

• Haidi KaramAllah Ramadan, Professor

  Assiut University

  STUDY DIRECTOR

• Mohamed Abdelghani Soliman, lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abanoub Ayoub Melk, assistant lecturer

CONTACT

01228261560; abanoub_ayoub@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: February 8, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

EG (1)