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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MR-based Models for Noninvasive Detection of Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)

Conditions
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Hypertension, Portal

Intervention / Treatment
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* Procedure: Transjugular HVPG measurement
* Procedure: MR imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm study<br>Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol. | Procedure: Transjugular HVPG measurement<br>* By means of catheterization of a hepatic vein with a balloon catheter.<br>Procedure: MR imaging<br>* MR images for the post-processing analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance of MR-based Models | Accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MR-based models for noninvasive detection of CSPH when compared to HVPG as the reference standard. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinically significant portal hypertension, hepatic venous pressure gradient, MR imaging