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EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors

NCT04695262 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-03-21

No results posted yet for this study

Summary

The differentiation among the Gastrointestinal Subepithelial Tumors (SETs) represents a clinical challenge. Endoscopic Ultrasound (EUS) alone may be ineffective in differentiating SETs subtypes, and tissue sampling of these lesions may be technically difficult. EUS Elastography (EUS-E) has been applied to many gastrointestinal diseases, providing a qualitative/semi-quantitative stiffness analysis, but only few studies have examined the role of EUS-E in the diagnosis of SETs. In addition, the use of contrast agents has improved the diagnostic performance of the EUS, especially in the differentiation between GISTs and other gastrointestinal SETs.

The aim of the study is to examine the performance of EUS-E and Contrast Enhanced-EUS (CE-EUS) in distinguishing among different gastrointestinal SETs subtypes. EUS patterns of different techniques will be compared to the final diagnosis gained by the analysis of histopatological specimens (surgical resection or EUS-FNB) or imaging/clinical follow-up.

Conditions

  • Gastrointestinal Subepithelial Tumors

Interventions

PROCEDURE

EUS-FNB

Endoscopic ultrasound (EUS)-guided fine needle biopsy (FNB)

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04695262 on ClinicalTrials.gov