Skip to main content
OpenTrials
Completed

NCT Number: NCT02842697

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension, Portal Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing 302 Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HVPG measurement

Procedure

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

CTA

Procedure

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

Doppler ultrasound

Procedure

Portal vein velocity measured by Doppler ultrasound

Primary outcomes

  1. Diagnostic Accuracy of vHVPG

    Time frame: 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 outcomes

  1. Diagnostic Performance of vHVPG

    Time frame: 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)

  2. vHVPG Numerical Correlation

    Time frame: 1 day

    Correlation of the vHVPG numerical value with the HVPG numerical value

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • Beijing 302 Hospital
  • Beijing Shijitan Hospital, Capital Medical University

Registry information

Official study title

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

Acronym: vHVPG

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 25, 2016
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.