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

Gastrointestinal Subepithelial Tumors Clinical Trial

— SUNNYDAY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04695262
• Other study ID #: 1800
• Status: Recruiting
• Start date: January 27, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Istituto Clinico Humanitas
• Contact: Silvia Carrara, MD
• Phone: 0039-02-82247388
• Email: silvia.carrara[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Subepithelial Tumors

Intervention

Procedure:
• EUS-FNB
Endoscopic ultrasound (EUS)-guided fine needle biopsy (FNB)

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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