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

EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04695262

Acronym

SUNNYDAY

Enrollment

Registered

2021-01-05

Start date

2021-01-27

Completion date

2023-12-31

Last updated

2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Subepithelial Tumors

Brief 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.

Interventions

PROCEDUREEUS-FNB

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
EUS-E accuracy in terms of qualitative and quantitative elastography	24 months	Evaluation of EUS-E accuracy (qualitative and quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs.

Countries

Italy

Contacts

Primary ContactSilvia Carrara, MD

silvia.carrara@humanitas.it0039-02-82247388

Backup ContactAlessandro Repici, MD

alessandro.repici@hunimed.eu0039-02-82247493

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026