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

March 20, 2023 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Endoscopy Unit, Humanitas Research Hospital
        • Sub-Investigator:
          • Milena Di Leo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with subepithelial gastrointestinal tumors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

January 2, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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