Mediastinal ( Chest) MassesNCT07419191
Role of Endoscopic Ultrasound Elastography in Diagnosis of Gastrointestinal Subepithelial and Mediastinal Lesions
An observational study of Mediastinal ( Chest) Masses and Gastrointestinal Subepithelial Tumors, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal ( Chest) Masses, Gastrointestinal Subepithelial Tumors
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- 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
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: During diagnostic procedure and after histopathological confirmation (within 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start8 Feb 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mediastinal ( Chest) MassesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Ayoub Melk, Assiut University
- Investigators
- Madiha Mohamed El Attar, professor, Study director, Assiut UniversityHaidi KaramAllah Ramadan, Professor, Study director, Assiut UniversityMohamed Abdelghani Soliman, lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419191
- Sponsor's protocol ID
- EUS in Mediastinal &GI lesions
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 28938687Verma 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 23549813Varanese 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 39459482Takeda 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 12722093Schofield PF, Hulton NR, Baildam AD. Is it acute cholecystitis? Ann R Coll Surg Engl. 1986 Jan;68(1):14-6.
PubMed 3511830Lardinois 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 12815135Detterbeck 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 23649434Carder 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 32055952Annema 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endoscopic Ultrasound Elastography in Diagnosis of Gastrointestinal Subepithelial and Mediastinal Lesions
- ClinicalTrials.gov ID
- NCT07419191
- Acronym / sponsor ID
- EUS in Mediastinal &GI lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Feb 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (4 listed)
- Age: Adults ≥ 12 years.
- 2- subepithelial lesions lesion detected by endoscopy .
Key exclusion criteria (4 listed)
- • patient Refusal or inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 28938687Liu 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.
- Results publication: PubMed 23549813Verma 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.
- Results publication: PubMed 39459482Varanese 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.
- Results publication: PubMed 12722093Takeda 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.
- Results publication: PubMed 3511830Schofield PF, Hulton NR, Baildam AD. Is it acute cholecystitis? Ann R Coll Surg Engl. 1986 Jan;68(1):14-6.
- Results publication: PubMed 12815135Lardinois 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.
- Results publication: PubMed 23649434Detterbeck 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.
- Results publication: PubMed 32055952Carder 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.
- Results publication: PubMed 16118383Annema 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mediastinal ( Chest) Masses and Gastrointestinal Subepithelial Tumors, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abanoub Ayoub Melk, assistant lecturer (01228261560, abanoub_ayoub@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07419191, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.