CEH-EUS for Differentiating GISTs and Leiomyomas: A Multicenter Prospective Self-Controlled Study

Sponsor
Huazhong University of Science and Technology
Study ID
NCT07106411
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Gastrointestinal Stromal Tumor (GIST)
  • Leiomyoma
  • Submucosal Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Ultrasound — DIAGNOSTIC_TEST
    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.
  • Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
288 participants (estimated)

Arms

  • Arm: All Participants
    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.

Primary Outcome Measure

Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma [ Time Frame: Within 1 month after final histopathological diagnosis ]

Central Contacts

Related Studies