MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Hypertension, Portal

Treatments: Procedure: MR imaging; Procedure: Transjugular HVPG measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03766880

CHESS1802

Details and patient eligibility

About

Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.

This is a multi-center diagnostic trial conducted at high-volume liver centres designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.

Full description

Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.

This is a multi-center diagnostic trial conducted at high-volume liver centres (Zhongda Hospital, Medical School of Southeast University; Affiliated Lishui Hospital of Zhejiang University; Shandong Provincial Hospital affiliated to Shandong University; Beijing 302 Hospital; Xingtai People's Hospital; Shunde Hospital, Southern Medical University; The First Hospital of Zhengzhou University; Shanghai Public Health Clinical Center, Fudan University; The First Hospital of Lanzhou University; Nanfang Hospital of Southern Medical University; Ankara University School of Medicine) designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.

Enrollment: 175 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-75 years
• With written informed consent
• Confirmed liver cirrhosis based on liver biopsy or clinical findings
• Scheduled to undergo clinically-indicated transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
• Has undergone> MR imaging within 14 days to hepatic vein catheterization
• No hepatic-portal vein interventional therapy between MR imaging and hepatic vein catheterization

Exclusion criteria

• A contraindication to MR imaging, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
• Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MR imaging studies
• Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection.
• Prior transjugular intrahepatic portosystem stent-shunt surgery
• Prior devascularization operation
• Has received a liver transplant
• Any active, serious, life-threatening disease

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

Single arm study

Experimental group

Description:

Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.

Treatment:

Procedure: Transjugular HVPG measurement

Procedure: MR imaging