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

Launched by HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jul 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special type of ultrasound called contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) to help doctors tell the difference between two types of growths in the digestive tract: gastrointestinal stromal tumors (GISTs) and leiomyomas. These growths can look similar but may need different treatments, so this test could improve how they are diagnosed and help predict how risky the GISTs might be. The study is being done at multiple centers and aims to see how well this ultrasound method works in real patients.

People who might be eligible for this study are adults between 18 and 85 years old who have a growth under the lining of their digestive tract that has already been seen on a standard endoscopy and are scheduled for this special ultrasound test. To join, participants must have good quality ultrasound images taken with specific equipment, and their condition must be confirmed by previous tissue tests or surgery. During the study, participants will receive an injection of a contrast agent (a safe substance that helps the ultrasound show clearer images) and undergo the CEH-EUS procedure, which involves a short video recording of the tumor. The study excludes people who are pregnant, have certain health problems, or have allergies to the contrast agent. If you qualify and decide to join, you will be closely monitored to help improve diagnosis and care for these types of tumors.

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Eligibility criteria

• 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).