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

Nanfang Hospital, Southern Medical University102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

102

Conditions

Hypertension, Portal

Interventions

HVPG measurementPROCEDURE

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

CTAPROCEDURE

Three-dimensional hepatic vein-portal vein model constructed with CTA images

Doppler ultrasoundPROCEDURE

Portal vein velocity measured by Doppler ultrasound

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Beijing 302 Hospital

Beijing, Beijing Municipality, China

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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)

Time frame: 1 day

Secondary Outcomes

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)

Time frame: 1 day

vHVPG Numerical Correlation

Correlation of the vHVPG numerical value with the HVPG numerical value

Time frame: 1 day