Not Yet RecruitingNot Applicable

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

China288 participantsStarted 2025-08

Plain-language summary

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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Equipment requirements: EU-ME2 processor (Olympus, Tokyo, Japan) and GF-UCT260 / GF-UE260 echoendoscope (Olympus, Tokyo, Japan);
✓. 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.);
✓. 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.

What they're measuring

Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma

Timeframe: Within 1 month after final histopathological diagnosis

Accuracy of CE-EUS and EUS in predicting malignant potential (risk stratification) of gastrointestinal stromal tumors

Timeframe: Within 1 month after final histopathological diagnosis

Trial details

NCT IDNCT07106411

SponsorHuazhong University of Science and Technology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Bin Cheng

13986097542 b.cheng@tjh.tjmu.edu.cn

View on ClinicalTrials.gov More Submucosal Tumor trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Equipment requirements: EU-ME2 processor (Olympus, Tokyo, Japan) and GF-UCT260 / GF-UE260 echoendoscope (Olympus, Tokyo, Japan);
✓. 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.);
✓. 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.

What they're measuring

Diagnostic accuracy of CE-EUS and EUS for differentiating GIST from leiomyoma

Timeframe: Within 1 month after final histopathological diagnosis

Accuracy of CE-EUS and EUS in predicting malignant potential (risk stratification) of gastrointestinal stromal tumors

Timeframe: Within 1 month after final histopathological diagnosis