About this trial
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.
Eligibility criteria
Qualifiers
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.);
Disqualifiers
Age <18 years or >85 years;
Hemoglobin level ≤8.0 g/dL;
Known allergy or hypersensitivity to ultrasound contrast agents;
Pregnant women;
Trial design
Treatments tested in this trial
- Endoscopic Ultrasound
- Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)
Treatment groups
Sponsors and collaborators
Huazhong University of Science and Technology
Lead sponsor
Zhongnan Hospital
Collaborator
Wuhan Central Hospital
Collaborator