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

Not yet recruiting

• Conditions: Portal Hypertension Related to Cirrhosis; Esophageal Varices

• Registration Number: NCT07122622
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-02
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-08-30
• Primary Completion: 2027-08
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CSPH	2 years	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.

Secondary Outcome Measures

Name	Time	Method
HRV	2 years	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; * Endoscopic data: esophageal varices classified as F1, F2, F3 and with/without red spots.