Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

Study Overview
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Brief Summary
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This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis.

Detailed Description
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Hepatic venous pressure gradient (HVPG) is the gold standard for assessing portal pressure, of which the measurement is invasive and therefore not suitable for routine clinical practice. The detection of serum biomarkers is potential for noninvasive diagnosis of portal hypertension in cirrhosis. However, many are still in the exploratory phases of testing and are not yet ready to enter clinical practice. This study prospectively enrolled participants in 6 liver centers (Beijing YouAn Hospital, Shandong Provincial Hospital, Beijing Shijitan Hospital, Beijing Friendship Hospital, Xingtai People's Hospital, and 302 Hospital of PLA) in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and HVPG in cirrhosis.

Official Title
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Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

Conditions
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Hypertension, Portal

Intervention / Treatment
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* Procedure: HVPG measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-75 years; confirmed cirrhosis based on histologic examination of liver or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver. Exclusion Criteria: prior drug therapy (e.g. β-blocker, vasopressin) within two weeks prior surgeries (e.g. TIPS, partial splenic embolization/ devascularization, splenectomy, liver transplantation) non-sinusoidal portal hypertension & HCC inability to adhere to study procedures pregnancy or unknown pregnancy status no informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Overall eligible participants<br>Eligible participants will receive HVPG measurement by catheterization of a hepatic vein with a balloon catheter and run blood tests. | Procedure: HVPG measurement<br>* HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.<br>* Other names: Blood test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between serum biomarkers and HVPG | Correlation between serum biomarkers and HVPG | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between serum biomarkers and HVPG in HBV subgroup | Correlation between serum biomarkers and HVPG in a subgroup of patients with HBV-related cirrhosis | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Portal hypertension, serum biomarker, diagnosis