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

NCT07106411 | Not Yet Recruiting DMC

• 1 other identifier: CEH-EUS 2025
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Submucosal Tumor; Gastrointestinal Stromal Tumor (GIST); Leiomyoma

Keywords

Endoscopic ultrasound; Contrast-Enhanced Ultrasonography

Outcome Measures

Primary Outcomes (2)

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

  The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.

  Within 1 month after final histopathological diagnosis

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

  The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of CE-EUS and conventional EUS will be calculated based on histopathological diagnosis as the gold standard.

  Within 1 month after final histopathological diagnosis

Secondary Outcomes (3)

• Comparison of CEH-EUS Imaging Characteristics Between GIST and Leiomyoma

  Within 1 month after histopathological diagnosis

• Quantitative TIC Parameter Analysis for Differential Diagnosis and Risk Stratification

  Within 1 month after histopathological diagnosis

• Correlation of CEH-EUS Perfusion Parameters with Tumor Type and Risk Classification

  Within 1 month after histopathological diagnosis

Study Arms (1)

All Participants

All enrolled patients with upper gastrointestinal subepithelial lesions confirmed by histopathology. Each participant underwent both endoscopic ultrasound (EUS) and contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) examinations.

Diagnostic Test: Endoscopic Ultrasound; Diagnostic Test: Contrast-Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS)

Interventions

Endoscopic Ultrasound DIAGNOSTIC_TEST

Conventional EUS will be performed to evaluate lesion size, echogenicity, border, and layer of origin for differentiation between GISTs and leiomyomas and risk stratification of GISTs.

All Participants

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

CEH-EUS will be conducted using a contrast agent to assess vascularity and enhancement patterns of the lesion for differentiation between GISTs and leiomyomas and risk stratification of GISTs.

All Participants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants aged 18-85 years with gastrointestinal subepithelial lesions identified by endoscopy, undergoing both EUS and CEH-EUS for diagnostic evaluation. Only patients with histologically confirmed GISTs or leiomyomas will be included.

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• Zhongnan Hospital: collaborator
• Wuhan Central Hospital: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (17)

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MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Leiomyoma

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Bin Cheng

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)