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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-30

Study Completion Date

2022-06-01

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.

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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.

Conditions

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Hypertension, Portal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Overall eligible participants

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

HVPG measurement

Intervention Type PROCEDURE

HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.

Interventions

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HVPG measurement

HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.

Intervention Type PROCEDURE

Other Intervention Names

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Blood test

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No