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

NCT04695262 | Unknown

• 1 other identifier: 1800
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Subepithelial Tumors

Outcome Measures

Primary Outcomes (1)

• EUS-E accuracy in terms of qualitative and quantitative elastography

  Evaluation of EUS-E accuracy (qualitative and quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs.

  24 months

Interventions

EUS-FNB PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with subepithelial gastrointestinal tumors

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Central Study Contacts

Silvia Carrara, MD

CONTACT

0039-02-82247388; silvia.carrara@humanitas.it

Alessandro Repici, MD

CONTACT

0039-02-82247493; alessandro.repici@hunimed.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 5, 2021
• Study Start: January 27, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)