Noninvasive Prediction of Portal Hypertension in Cirrhosis Using Sound Touch Viscoelastography

NCT06316869 | Recruiting DMC

• 1 other identifier: STVi
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this observational study is to investigate and validate the utility of the Sound Touch Viscoelastography(STVi) technique in patients with liver cirrhosis for noninvasive prediction of Portal hypertension (PH). The primary research questions it seeks to address are as follows:

• What is the correlation between the liver STVi index and Portal Venous Pressure Gradient (HVPG)?
• Is STVi an available tool to non-invasively predict PH in patients with liver cirrhosis? And the effectiveness and practicality of STVi will be validated.
• To establish a predictive model for Clinically Significant Portal Hypertension (CSPH) utilizing liver STVi index as the primary indicator. The HVPG is considered as the gold standard in this study and STVi was employed to quantify the STVi index of the liver in patients with liver cirrhosis. Researchers will compare the two patients groups, HVPG≥10 mmHg and HVPG\<10 mmHg, to see the usage of STVi in the noninvasive prediction of PH.

Conditions

Portal Hypertension; Cirrhosis

Keywords

Sound Touch Viscoelastography; Clinically Significant Portal Hypertension; Portal Venous Pressure Gradient; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• The STVi index

  The ultrasound STVi index is derived from the acoustic factors that describe the variation of shear wave speed with frequency. The abdominal convex array probe equipped with the color Doppler ultrasound system (including elastic components) was used to measure the shear wave signals.This index is calculated using the Voigt model and a linear relationship model to determine viscosity and dispersion, employing specific computer algorithms to obtain the final value. Since the STVi index is a new evaluation metric based on novel ultrasound technology, no clear maximum or minimum values have been reported. STVi index is significantly higher in the CSPH group than in the non-CSPH group.

  baseline, pre-intervention

Study Arms (2)

CSPH group

HVPG≥10 mmHg

Diagnostic Test: ultrasound test

Non-CSPH group

HVPG\<10 mmHg

Diagnostic Test: ultrasound test

Interventions

ultrasound test DIAGNOSTIC_TEST

Conventional gray-scale ultrasound and color Doppler examination: including hepatic artery inner diameter, hepatic artery peak flow velocity, hepatic artery resistance index, portal vein trunk inner diameter, portal vein average flow velocity, spleen size, etc. STVi detection: Use the color Doppler ultrasound system (including elastic components) of Shenzhen Mindray Biomedical Electronics Co., Ltd., equipped with an abdominal convex array probe with a probe frequency of 1\~6 MHz. The probe was placed in a supine position or slightly tilted to the left, with the right arm raised and fully abducted to increase the width of the intercostal space, and the liver viscoelastic index of the right lobe of the liver was measured between the intercostals. During measurement, the subject should hold his breath for 3 to 5 seconds in a calm state. Do not hold his breath after taking a deep breath. The sampling frame should be placed in a place with uniform echo in the liver parenchyma, avoiding large

CSPH group; Non-CSPH group

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

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.

You may qualify if:

• 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.

You may not qualify if:

• Post-TIPS procedure;
• Post-hepatectomy splenectomy;
• Hepatic malignancy;
• Portal vein thrombosis;
• Individuals with severe cardiac, pulmonary, hepatic, or renal dysfunction;
• Pregnant and postpartum women.

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325006, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Shihao Xu, doctor

CONTACT

+86 13857766918; dcxshvip@wmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 19, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)