Assessing liver and spleen stiffness to diagnose portal hypertension in chronic liver disease patients

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 observational diagnostic study aims to compare the effectiveness of liver stiffness and spleen stiffness measurements using 2D-shear wave elastography (2D-SWE) and transient elastography (TE) in diagnosing clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD). Participants will undergo a series of assessments, including demographic data collection, laboratory tests, and imaging studies, to evaluate their liver and spleen stiffness. The study will take place at the Fifth Affiliated Hospital, Sun Yat-Sen University, from October 2023 to January 2025.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age≥18 years old;
* Chronic liver disease (alcoholic liver disease, chronic hepatitis B, chronic hepatitis C or non-alcoholic fatty liver disease);
* Liver stiffness ≥10kPa measured by transient elastography (TE);
* No previous decompensation-related manifestations (such as ascites, gastrointestinal varicose bleeding, hepatic encephalopathy, etc.);
* Informed consent has been signed.

Exclusion Criteria:

* There are contraindications of hepatic venous pressure gradient (HVPG) measurement (such as severe abnormal coagulation function;
* Non-cirrhosis portal hypertension;
* Hepatocellular carcinoma or other advanced malignant tumor;
* Acute liver disease or ALT≥5×ULN;
* A history of splenectomy or splenic embolism;
* Acute or chronic thrombosis of the portal vein;
* Pregnancy or HIV infection;
* A history of using non-selective beta blockers (NSBB) or diuretic in the last 3 months;
* Persistent substance abuse other than alcohol;
* A history of transjugular intrahepatic portosystemic shunts (TIPs), endoscopic variceal ligation(EVL) , hardener or tissue gel therapy;
* There are conditions that seriously affect TE and 2D-SWE measurements (such as the intercostal space is too narrow, BMI≥30, etc.);
* Subjects considered unsuitable for including in this study but not included by the above exclusion criteria.

Where it's running

• The Fifth Affiliated Hospital, Sun Yat-sen University
  Zhuhai, Guangdong, China Recruiting

Study contacts

• Principal investigator: Xi Liu, PhD — The Fifth Affiliated Hospital, Sun Yat-sen University
• Study coordinator: Xi Liu, PhD
• Email: liuxi26@mail.sysu.edu.cn
• Phone: +86 15992670630

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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.