EUS for Gastrointestinal Disorders: a Registry

• Conditions: Pancreatic Disorders; GI Tract Disorders; EUS

• Registration Number: NCT02855151
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

The aim of the EUS registry is to record information about Endoscopic Ultrasound (EUS) on the management of gastrointestinal disease. The registry will evaluate efficacy, safety and technical success of the Endoscopic Ultrasound (EUS). Design is retrospective and prospective registry study.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-17
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• All patients submitted to EUS,
• Informed consent.

Exclusion Criteria

• Age less than 18 y
• Patient who did not give the consent to the processing of personal data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	2 days	Documentation of adverse events.

Secondary Outcome Measures

Name	Time	Method
Diagnostic yied of elastography during EUS	0 Day	sensitivity and specificity of EUS with elastography
Diagnostic yied of Contrast-Enhanced Endoscopic Ultrasonography	0 Day	sensitivity and specificity contrast medium
Tissue acquisition during EUS	0 Days	sensitivity and specificity of tissue acquisition

Trial Locations

Locations (1)

Endoscopy Unit, Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy