Noninvasive Prediction of Portal Hypertension in Cirrhosis Using STVi

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study enrolling adults with cirrhosis to compare the noninvasive liver STVi index with the HVPG, the current gold standard for portal hypertension. The goal is to see how well STVi correlates with HVPG and to develop a predictive model for CSPH using STVi as the primary indicator. Participants undergo standard clinical and laboratory assessments, conventional ultrasound with Doppler, and STVi measurements, all within a short window around HVPG testing. The study aims to validate STVi as a practical, noninvasive tool for predicting portal hypertension in cirrhosis. Lead site is the First Affiliated Hospital of Wenzhou Medical University in Zhejiang, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• the First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Shihao Xu, doctor
• Email: dcxshvip@wmu.edu.cn
• Phone: +86 13857766918

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.