Hypertension, Portal
Conditions
Keywords
Portal hypertension, serum biomarker, diagnosis
Brief summary
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
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.
Interventions
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between serum biomarkers and HVPG | 1 day | Correlation between serum biomarkers and HVPG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between serum biomarkers and HVPG in HBV subgroup | 1 day | Correlation between serum biomarkers and HVPG in a subgroup of patients with HBV-related cirrhosis |
Countries
China