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NCT Number: NCT07122622

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

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.

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Key information

Conditions

Portal Hypertension Related to Cirrhosis Digestive System Diseases Esophageal Diseases Esophageal Varices Esophageal and Gastric Varices Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ultrasound diagnostic and interventional service "Policlinico A.Gemelli"

Roma, Italia, 00168, Italy

Location status: Recruiting

Location contact

Garcovich

CONTACT

[email protected]

0630155052

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. CSPH

    Time frame: 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 outcomes

  1. HRV

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matteo Garcovich doctor

CONTACT

[email protected]

0039 0630156018

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Role of 2D-shear Wave Spleen Elastography in Assessing Clinically Significant Portal Hypertension and High-risk Varices in Patients With Advanced Compensated Chronic Liver Disease.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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