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

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.

Sex

All

Minimum age

18 Years

Maximum age

85 Years

Inclusion Criteria:

* 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;
* EUS image quality meets the following quality control standards:

  1. Equipment requirements: EU-ME2 processor (Olympus, Tokyo, Japan) and GF-UCT260 / GF-UE260 echoendoscope (Olympus, Tokyo, Japan);
  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.);
  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.
* 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;
* Written informed consent is obtained.

Exclusion Criteria:

* Age \<18 years or \>85 years;
* Hemoglobin level ≤8.0 g/dL;
* Known allergy or hypersensitivity to ultrasound contrast agents;
* Pregnant women;
* Severe cardiopulmonary dysfunction that precludes tolerance of endoscopic ultrasound examination;
* Inability to provide written informed consent (e.g., due to psychiatric disorders or substance abuse).

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