[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"submucosal-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:submucosal-tumor":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100601124","ceh-eus-for-differentiating-gists-and-leiomyomas-a-multicenter-prospective-self-controlled-study-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":20,"type":21},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.",[25,26,27],"Submucosal Tumor","Gastrointestinal Stromal Tumor (GIST)","Leiomyoma",[29,30],"Endoscopic ultrasound","Contrast-Enhanced Ultrasonography","NOT_YET_RECRUITING","2025-07-30",{"date":34,"type":35},"2025-08-06","ACTUAL",{"date":37,"type":21},"2025-08",{"date":39,"type":21},"2026-10",{"name":41,"class":42},"Huazhong University of Science and Technology","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100598949","multicenter-observational-study-of-multimodal-ai-for-upper-gi-mesenchymal-tumor-diagnosis-100598949","NCT07078136","Multicenter Observational Study of Multimodal AI for Upper GI Mesenchymal Tumor Diagnosis","Multicenter Observational Study of a Multimodal AI Model Using EUS, White-Light Endoscopy, and Clinical Data for Diagnosis of Upper GI Mesenchymal Tumors and Risk Stratification of Gastric GISTs","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with an upper gastrointestinal subepithelial lesion (SEL) identified by white-light endoscopy and who have completed an endoscopic ultrasound (EUS) examination\n* Patients with a histopathological diagnosis of GIST confirmed by surgical or endoscopic resection, or other SELs confirmed by surgical resection, EUS-guided sampling, or other biopsy techniques\n* EUS image quality meets the following quality control standards\n\n  1. Equipment requirements: Olympus EU-ME2\u002FME1 processor (Olympus Medical Systems Corp., Tokyo, Japan); radial EUS scope (GF-UE260\u002FGF-UE240; Olympus, Tokyo, Japan) or linear EUS scope (GF-UCT260\u002FGF-UCT240; Olympus, Tokyo, Japan); miniature probe (UM2R\u002F3R; Olympus, Tokyo, Japan); Pentax ARIETTA 850 processor (Pentax, Tokyo, Japan); radial EUS scope (EG-3670URK, Pentax, Tokyo, Japan); linear EUS scope (EG-3870UT, Pentax, Tokyo, Japan); Fujifilm SU-8000 or SU-9000 processor; linear EUS scope (EG-580UT, Fujifilm, Tokyo, Japan); radial EUS scope (EG-580UR, Fujifilm, Tokyo, Japan)\n  2. EUS images clearly showing the lesion and surrounding tissue characteristics (at least 5 images or video); must include at least one image of the maximum lesion diameter, one image showing the layer of origin, and one image demonstrating the growth pattern (intraluminal\u002Fextraluminal)\n  3. EUS images must not contain artificial annotations, such as measurement scales, biopsy needles, Doppler signals, or elastography overlays\n  4. Image resolution must be at least 448 × 448 pixels\n* WLE (white-light endoscopy) image quality meets the following standards: images must clearly show the lesion location, mucosal features, and margins; at least one close-up and one distant view\n* Complete clinical data and histopathological reports must be available\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Absolute contraindications for EUS examination, history of gastric surgery, pregnancy, severe comorbidities, or known allergy to anesthetic agents\n* EUS examination terminated prematurely due to esophageal stricture, obstruction, large space-occupying lesions, rapid changes in heart rate or respiratory rate, patient intolerance, or excessive residual food\n* EUS image quality does not meet the required quality control standards\n* Pathological specimens do not meet diagnostic requirements: insufficient biopsy tissue (only R0 resection specimens are accepted for the GIST group), or incomplete immunohistochemical staining (missing CD117\u002FCD34\u002FDOG-1 expression report for the GIST group)\n* Pathological results indicate that the lesion is a metastatic tumor originating from another site",{"count":52,"type":21},130,"This study develops a multimodal AI model using endoscopic ultrasound, white-light endoscopy, and clinical information to support the diagnosis of upper GI mesenchymal tumors and the risk stratification of gastric GISTs.",[25,26,27,55],"Schwannoma",[57,29,58],"Artificial Intelligence","white-light endoscopy","RECRUITING","2025-07-28",{"date":62,"type":35},"2025-07-31",{"date":60,"type":35},{"date":65,"type":21},"2026-06",{"name":41,"class":42}]