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
Trial ID: NCT07078136
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-07-28
Completion date: 2026-06
Sponsor: Huazhong University of Science and Technology
Conditions: Submucosal Tumor; Gastrointestinal Stromal Tumor (GIST); Leiomyoma; Schwannoma
Interventions: Multimodal AI Model; Expert Endoscopist Assessment
Locations: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Countries: China
Enrollment: 130
Age range: 18 Years - None
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patients with an upper gastrointestinal subepithelial lesion (SEL) identified by white-light endoscopy and who have completed an endoscopic ultrasound (EUS) examination
* 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
* EUS image quality meets the following quality control standards

  1. Equipment requirements: Olympus EU-ME2/ME1 processor (Olympus Medical Systems Corp., Tokyo, Japan); radial EUS scope (GF-UE260/GF-UE240; Olympus, Tokyo, Japan) or linear EUS scope (GF-UCT260/GF-UCT240; Olympus, Tokyo, Japan); miniature probe (UM2R/3R; 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)
  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/extraluminal)
  3. EUS images must not contain artificial annotations, such as measurement scales, biopsy needles, Doppler signals, or elastography overlays
  4. Image resolution must be at least 448 × 448 pixels
* 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
* Complete clinical data and histopathological reports must be available

Exclusion Criteria:

* Age \< 18 years old
* Absolute contraindications for EUS examination, history of gastric surgery, pregnancy, severe comorbidities, or known allergy to anesthetic agents
* 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
* EUS image quality does not meet the required quality control standards
* 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/CD34/DOG-1 expression report for the GIST group)
* Pathological results indicate that the lesion is a metastatic tumor originating from another site

Outcomes:
Diagnostic accuracy of a multimodal AI model for differentiating gastrointestinal stromal tumors (GISTs) from other upper gastrointestinal mesenchymal tumors; Predictive accuracy of the multimodal AI model for risk stratification of GISTs