Clinical trial · Observational
Role of Endoscopic Ultrasound Elastography in Diagnosis of Gastrointestinal Subepithelial and Mediastinal Lesions
NCT07419191CI-TRIAL-00103511not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Subepithelial Tumors | — | UNRESOLVED | — |
| Mediastinal ( Chest) Masses | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic yield of endoscopic ultrasound in mediastinal lesions and gastrointestinal subepithelial lesions
- timeFrame
- At time of diagnostic procedure and after histopathological confirmation (within 2 weeks)
- description
- 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 outcomes (1)
- measure
- Diagnostic accuracy of endoscopic ultrasound elastography for differentiating benign from malignant mediastinal and gastrointestinal subepithelial lesions
- timeFrame
- During diagnostic procedure and after histopathological confirmation (within 2 weeks)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (9)
- BACKGROUNDLiu 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
- RESULTVerma 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
- RESULTVaranese 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
- RESULTTakeda 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
- RESULTSchofield PF, Hulton NR, Baildam AD. Is it acute cholecystitis? Ann R Coll Surg Engl. 1986 Jan;68(1):14-6. PMID 3511830
- RESULTLardinois 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
- RESULTDetterbeck 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.