[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601124":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":10,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":49,"id":54,"slug":10,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Huazhong University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All Participants",null,"All enrolled patients with upper gastrointestinal subepithelial lesions confirmed by histopathology. Each participant underwent both endoscopic ultrasound (EUS) and contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) examinations.",[13,14],"Diagnostic Test: Endoscopic Ultrasound","Diagnostic Test: Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DIAGNOSTIC_TEST","Endoscopic Ultrasound","Conventional 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.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)","CEH-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.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Bin Cheng","CONTACT","13986097542","b.cheng@tjh.tjmu.edu.cn",[32],{"facility":33,"status":10,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430030","China",{"type":39,"coordinates":40},"Point",[41,42],114.26667,30.58333,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},{"type":47,"investigatorFullName":27,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","prof.",[50,52],{"name":51,"class":6},"Zhongnan Hospital",{"name":53,"class":6},"Wuhan Central Hospital","100601124",false,"NCT07106411","CEH-EUS for Differentiating GISTs and Leiomyomas: A Multicenter Prospective Self-Controlled Study","Contrast-Enhanced Harmonic Endoscopic Ultrasound for the Differential Diagnosis Between Gastrointestinal Stromal Tumors and Leiomyomas: A Multicenter Prospective Self-Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years and ≤ 85 years;\n* Subepithelial lesion in the gastrointestinal tract identified under white-light endoscopy and scheduled for CEH-EUS examination to determine the nature of the lesion;\n* EUS image quality meets the following quality control standards:\n\n  1. Equipment requirements: EU-ME2 processor (Olympus, Tokyo, Japan) and GF-UCT260 \u002F GF-UE260 echoendoscope (Olympus, Tokyo, Japan);\n  2. 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.);\n  3. CEH-EUS procedure: Use of extended pure harmonic detection (Ex-PHD) mode with mechanical index (MI) adjusted to 0.3; 2.4 mL of SonoVue contrast agent is injected via the elbow vein within 2-3 seconds, followed by a 5 mL saline flush; real-time dynamic image acquisition continues for 120 seconds, and video recording is collected.\n* Patients with GIST confirmed by surgical or endoscopic resection pathology, and patients with leiomyoma confirmed by surgical resection, EUS-guided tissue sampling, or other biopsy techniques;\n* Written informed consent is obtained.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>85 years;\n* Hemoglobin level ≤8.0 g\u002FdL;\n* Known allergy or hypersensitivity to ultrasound contrast agents;\n* Pregnant women;\n* Severe cardiopulmonary dysfunction that precludes tolerance of endoscopic ultrasound examination;\n* Inability to provide written informed consent (e.g., due to psychiatric disorders or substance abuse).","ALL","18 Years","85 Years",{"count":64,"type":65},288,"ESTIMATED","OBSERVATIONAL","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.",[69,70,71],"Submucosal Tumor","Gastrointestinal Stromal Tumor (GIST)","Leiomyoma",[73,74],"Endoscopic ultrasound","Contrast-Enhanced Ultrasonography","NOT_YET_RECRUITING","2025-07-30",{"date":78,"type":79},"2025-08-06","ACTUAL",{"date":81,"type":65},"2025-08",{"date":83,"type":65},"2026-10",{"name":5,"class":6},1]