Ultrasound may replace invasive test for dangerous liver complication

NCT ID NCT06316869

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First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing a new ultrasound technique called Sound Touch Viscoelastography (STVi) to see if it can predict portal hypertension in people with cirrhosis without needing an invasive procedure. The study compares STVi measurements of the liver with the standard invasive pressure test, called HVPG, in 216 adults with cirrhosis. The goal is to find out whether STVi can accurately identify clinically significant portal hypertension and help doctors make treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sound Touch Viscoelastography (STVi), an ultrasound-based diagnostic technique
What this could lead to
If it works, this ultrasound method could offer a noninvasive way to estimate portal hypertension and help doctors identify patients who need closer monitoring or treatment.
What could go wrong
The technique is new and unproven, so it may not match the accuracy of the invasive gold standard. Results from this single-center study may not apply to all patients with cirrhosis.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Portal Hypertension (PH) is the primary consequence of liver cirrhosis and a crucial factor leading to severe complications such as ascites, rupture and bleeding of esophageal and gastric varices (EGV), and hepatic encephalopathy. It annually results in a significant number of deaths, posing a serious threat to life and health. In China, there is a large population of PH patients, and the long-term follow-up and treatment processes require substantial medical resources. Currently, there is no reliable non-invasive method for convenient and rapid monitoring of portal vein pressure in PH patients. This hinders timely clinical intervention and compromises patient prognosis.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age older than 18 years. * Clinically diagnosed with cirrhosis. Meeting the diagnostic criteria of the 2019 edition of the "Cirrhosis Diagnosis and Treatment Guidelines": (1) Histology consistent with cirrhosis diagnosis; (2) Endoscopy shows esophageal gastric varices or ectopic varices, excluding non-cirrhotic portal hypertension; (3) Imaging examinations such as ultrasound, LSM, or CT suggest features of cirrhosis or portal hypertension: such as splenomegaly, portal vein ≥1.3 cm, LSM measurements meeting diagnostic thresholds for cirrhosis of different etiologies; (4) In the absence of histology, endoscopy, or imaging examinations, the following abnormal indicators suggest the presence of cirrhosis (must meet 2 of the 4 criteria): a. PLT \<100×10\^9/L, with no other explanations; b. Serum ALB \<35 g/L, excluding malnutrition or other causes such as renal disease; c. INR \>1.3 or prolonged PT (discontinuation of thrombolytics or anticoagulants for \>7 days); d. AST/PLT ratio index (APRI): Adult APRI score \>2, with attention to the influence of hepatotoxic drugs and other factors on APRI. * Planning to undergo HVPG testing and meeting the indications for HVPG testing in the "Chinese Expert Consensus on the Clinical Application of Hepatic Venous Pressure Gradient (2018 edition)" : (1) Assessing the efficacy of drug therapy for primary and secondary prevention of esophageal gastric variceal bleeding; (2) Predicting the risk of esophageal gastric variceal bleeding and guiding treatment plan selection; (3) Predicting the risk, degree of progression, and clinical prognosis of decompensated events in cirrhosis; (4) Evaluating the efficacy of related new drugs; (5) Evaluating the accuracy of related non-invasive techniques; (6) Diagnosis and differential diagnosis of portal hypertension types. * Able to understand and voluntarily sign a written informed consent form. Exclusion Criteria: * Post-TIPS procedure; * Post-hepatectomy splenectomy; * Hepatic malignancy; * Portal vein thrombosis; * Individuals with severe cardiac, pulmonary, hepatic, or renal dysfunction; * Pregnant and postpartum women.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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Contacts and locations

Locations

  • the First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325006, China

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