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

Locations

1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology430030, WuhanHubei, China

Sponsors and collaborators

Huazhong University of Science and Technology

Lead sponsor

Zhongnan Hospital

Collaborator

Wuhan Central Hospital

Collaborator