2D-shear Wave Spleen Elastography in Clinically Significant Portal Hypertension and High-risk Varices

NCT07122622 | Recruiting

• 1 other identifier: 7514
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV) in patients with CSPH. Secondary objectives of the study include the investigation of the correlation between SWE-SSM and portal pressure in a subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement and between SWE-SSM and transient elastography (TE-SSM). The values of SWE-SSM and SWE-LSM will be assessed during the ultrasound examination to which the patient will be subjected according to their care pathway. If inclusion criteria are met and informed consent is obtained, spleen elastography will be carried out (in addition to the routine SWE-LSM planned in clinical practice). Spleen elastography will not alter the standard ultrasound examination but represents a non-invasive diagnostic addition. There will be no treatment or experimental intervention that will modify the patient's condition or directly influence their clinical course. The aim is to collect data based on clinical observations without altering the treatment or the natural course of the disease.

Conditions

Portal Hypertension Related to Cirrhosis; Esophageal Varices

Outcome Measures

Primary Outcomes (1)

• CSPH

  The following data will be collected: * Shear Wave Elastography of the spleen (SWE-SSM): continuous variable, expression of splenic stiffness, measured in kPa; * Shear Wave Elastography of the liver (SWE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa; * Transient Elastography of the spleen (TE-SSM): continuous variable, expression of splenic stiffness, measured in kPa; * Transient Elastography of the liver (TE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa; * Bipolar diameter of the spleen: measured in centimeters * Ascites yes/no; * Collateral circulation yes/no; * Encephalopathy yes/no; * Non selective beta-blockers yes/no; * Hepatic Venous Pressure Gradient (HVPG): continuous variable, portosystemic pressure gradient, measured in mmHg.

  2 years

Secondary Outcomes (1)

• HRV

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referring to the Diagnostic and Interventional Ultrasound UOSD of the digestive system disease center of the University Hospital Policlinico A.Gemelli of Rome to undergo an ultrasound of the upper abdomen as part of their clinical pathway.

You may qualify if:

• Age greater than 18 years;
• SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;

You may not qualify if:

• Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·
• Surgical absence of the spleen;
• Grade 3 ascites;
• History of variceal bleeding;
• Refusal to participate in the study.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"

Roma, Italia, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Central Study Contacts

Matteo Garcovich doctor

CONTACT

0039 0630156018; matteo.garcovich@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: August 14, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): August 20, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

IT (1)