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

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    50
  • sponsor
    Istituto Clinico Humanitas
Updated on 25 March 2021

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.

Details
Condition Gastrointestinal Subepithelial Tumors
Treatment EUS-FNB
Clinical Study IdentifierNCT04695262
SponsorIstituto Clinico Humanitas
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with GI SETs scheduled for EUS-FNB
Patients with age > 18 but <85 years

Exclusion Criteria

Patients with GI SETs <15mm
severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
severe cardiopulmonary diseases and severe chronic kidney disease defined as glomerular filtration rate (GFR) < 15 ml/min
known allergic disposition to SonoVue
pregnancy
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