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

NCT ID: NCT04695262

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-27

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Subepithelial Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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EUS-FNB

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Silvia Carrara, MD

Role: CONTACT

0039-02-82247388

Alessandro Repici, MD

Role: CONTACT

0039-02-82247493

Facility Contacts

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Alessandro Repici, MD

Role: primary

+39282247493

Other Identifiers

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1800

Identifier Type: -

Identifier Source: org_study_id

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