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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorHuazhong University of Science and Technology

About this trial

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.

Eligibility criteria

Qualifiers

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;

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.);

Disqualifiers

Age <18 years or >85 years;

Hemoglobin level ≤8.0 g/dL;

Known allergy or hypersensitivity to ultrasound contrast agents;

Pregnant women;

Trial design

Treatments tested in this trial

  • Endoscopic Ultrasound
  • Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)

Treatment groups

288 Participants
are divided into 1 treatment group

Sponsors and collaborators

Huazhong University of Science and Technology

Lead sponsor

Zhongnan Hospital

Collaborator

Wuhan Central Hospital

Collaborator