ClinicalTrials.Veeva

Menu

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

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Esophageal Varices
Portal Hypertension Related to Cirrhosis

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

Loading...

Central trial contact

Matteo Garcovich doctor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems