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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03713606
Enrollment
75
Registered
2018-10-22
Start date
2018-09-30
Completion date
2022-06-01
Last updated
2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Portal

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

Beijing YouAn Hospital
CollaboratorOTHER
Shandong Provincial Hospital
CollaboratorOTHER_GOV
Beijing Shijitan Hospital, Capital Medical University
CollaboratorOTHER
Beijing Friendship Hospital
CollaboratorOTHER
Xingtai People's Hospital
CollaboratorOTHER
Beijing 302 Hospital
CollaboratorOTHER
Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Correlation between serum biomarkers and HVPG1 dayCorrelation between serum biomarkers and HVPG

Secondary

MeasureTime frameDescription
Correlation between serum biomarkers and HVPG in HBV subgroup1 dayCorrelation between serum biomarkers and HVPG in a subgroup of patients with HBV-related cirrhosis

Countries

China

Contacts

Primary ContactXiaolong Qi, M.D.
qixiaolong@vip.163.com+86 18588602600
Backup ContactYanna Liu
lauyenna@126.com+86 15625076784

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026