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

Nanfang Hospital, Southern Medical University

Status

Unknown

Conditions

Hypertension, Portal

Treatments

Procedure: HVPG measurement

Study type

Observational

Funder types

Other

Identifiers

NCT03713606

Pan-CHESS1802

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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