Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601)

Study Overview
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Brief Summary
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This is a prospective, multi-center trial conducted at 1 Guangzhou and 2 Beijing centers designed to determine the diagnostic performance of virtual hepatic venous pressure gradient (vHVPG) (investigational technology) by anatomic computed tomographic angiography (CTA) for non-invasive assessment of the clinically significant portal hypertension (CSPH) in patients with compensated cirrhosis. Direct hepatic venous pressure gradient (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, which is defined as HVPG≥10 mmHg.

Detailed Description
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This is a prospective, multi-center trial conducted at 1 Guangzhou (Nanfang Hospital) and 2 Beijing (Beijing 302 Hospital, Beijing Shijitan Hospital) centers designed to determine the diagnostic performance of vHVPG (investigational technology) by anatomic CTA for non-invasive assessment of the CSPH in patients with compensated cirrhosis. Direct 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, which is defined as HVPG≥10 mmHg.

Official Title
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Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension

Conditions
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Hypertension, Portal

Intervention / Treatment
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* Procedure: HVPG measurement
* Procedure: CTA
* Procedure: Doppler ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Patients providing written informed consent Patients with compensated cirrhosis and scheduled to undergo clinically-indicated invasive HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter Has undergone > 64 multi-detector row CTA within 14 days prior to hepatic vein catheterization No hepatic-portal vein interventional therapy between the CTA and hepatic vein catheterization Exclusion Criteria: Prior transjugular intrahepatic portosystem stent-shunt surgery Prior devascularization operation Has received a liver transplant Patients with known anaphylactic allergy to iodinated contrast Pregnancy or unknown pregnancy status Patient requires an emergent procedure Any active, serious, life-threatening disease Inability to adhere to study procedures

Ages Eligible for Study
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Minimum Age: 18 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>Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement | Procedure: HVPG measurement<br>* HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter<br>Procedure: CTA<br>* Three-dimensional hepatic vein-portal vein model constructed with CTA images<br>Procedure: Doppler ultrasound<br>* Portal vein velocity measured by Doppler ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy of vHVPG | Diagnostic accuracy of vHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance of vHVPG | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of vHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg) | 1 day | 
| vHVPG Numerical Correlation | Correlation of the vHVPG numerical value with the HVPG numerical value | 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, computed tomographic angiography