Role of Endoscopic Ultrasound Elastography in Diagnosis of Gastrointestinal Subepithelial and Mediastinal Lesions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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) .
Lesion accessibility: Lesion judged by the endosonographer to be accessible to EUS imaging and elastography and amenable to EUS-guided sampling
Disqualifiers
• 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 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 .
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: