The investigators conduct a prospective, multicenter diagnostic trial primarily aimed at evaluating the value of contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) in differentiating gastrointestinal stromal tumors (GISTs) from leiomyomas, as well as its predictive utility in the risk stratification of GISTs.
Age ≥18 years and ≤ 85 years;
Subepithelial lesion in the gastrointestinal tract identified under white-light endoscopy and scheduled for CEH-EUS examination to determine the nature of the lesion;
Equipment requirements: EU-ME2 processor (Olympus, Tokyo, Japan) and GF-UCT260 / GF-UE260 echoendoscope (Olympus, Tokyo, Japan);
Image acquisition: Five EUS still images clearly displaying the lesion and surrounding structures, including maximum lesion diameter, originating layer, Doppler signals, and internal echo characteristics; a 15-second video clearly demonstrating the lesion without any artificial annotations (e.g., scale, needle, Doppler signal, elastography, etc.);
Age <18 years or >85 years;
Hemoglobin level ≤8.0 g/dL;
Known allergy or hypersensitivity to ultrasound contrast agents;
Pregnant women;
All participants aged 18-85 years with gastrointestinal subepithelial lesions identified by endoscopy, undergoing both EUS and CEH-EUS for diagnostic evaluation. Only patients with histologically confirmed GISTs or leiomyomas will be included.
Cohort
Prospective
Endoscopic Ultrasound
Diagnostic testConventional EUS will be performed to evaluate lesion size, echogenicity, border, and layer of origin for differentiation between GISTs and leiomyomas and risk stratification of GISTs.
Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)
Diagnostic testCEH-EUS will be conducted using a contrast agent to assess vascularity and enhancement patterns of the lesion for differentiation between GISTs and leiomyomas and risk stratification of GISTs.
Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.
Accuracy of CE-EUS and EUS in predicting malignant potential (risk stratification) of gastrointestinal stromal tumors
The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.
Comparison of CEH-EUS Imaging Characteristics Between GIST and Leiomyoma
Contrast-enhancement patterns and perfusion characteristics will be recorded and compared between histologically confirmed GISTs and leiomyomas.
Quantitative TIC Parameter Analysis for Differential Diagnosis and Risk Stratification
TIC-based quantitative CEH-EUS parameters will be measured and evaluated for their ability to distinguish GIST from leiomyoma and to predict GIST risk stratification, compared against final histopathology.
Correlation of CEH-EUS Perfusion Parameters with Tumor Type and Risk Classification
CEH-EUS perfusion parameters such as enhancement intensity, wash-in rate, and wash-out rate will be analyzed for correlation with tumor type (GIST vs. leiomyoma) and with GIST risk levels based on NIH criteria.
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Huazhong University of Science and Technology
Lead sponsor
Zhongnan Hospital
Collaborator
Wuhan Central Hospital
Collaborator
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