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

• Conditions: Hypertension, Portal
• Interventions: Procedure: HVPG measurement

• Registration Number: NCT03713606
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2018-09-30
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17
• Primary Completion: 2022-01-31
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overall eligible participants	HVPG measurement	Eligible participants will receive HVPG measurement by catheterization of a hepatic vein with a balloon catheter and run blood tests.

Primary Outcome Measures

Name	Time	Method
Correlation between serum biomarkers and HVPG	1 day	Correlation between serum biomarkers and HVPG

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Shandong Provincial Hospital; 🇨🇳 Jinan, China

Beijing Friendship Hospital; 🇨🇳 Beijing, China

302 Hospital of PLA; 🇨🇳 Beijing, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, China

Beijing YouAn Hospital; 🇨🇳 Beijing, China

Xingtai People's Hospital; 🇨🇳 Xingtai, China