Hypertension, Portal
Conditions
Keywords
clinically significant portal hypertension, hepatic venous pressure gradient, computed tomographic angiography
Brief summary
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
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.
Interventions
PROCEDUREHVPG measurement
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter
PROCEDURECTA
Three-dimensional hepatic vein-portal vein model constructed with CTA images
PROCEDUREDoppler ultrasound
Portal vein velocity measured by Doppler ultrasound
Sponsors
Beijing 302 Hospital
Beijing Shijitan Hospital, Capital Medical University
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of vHVPG | 1 day | Diagnostic accuracy of vHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance of vHVPG | 1 day | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of vHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg) |
| vHVPG Numerical Correlation | 1 day | Correlation of the vHVPG numerical value with the HVPG numerical value |
Countries
China
Outcome results
None listed