Clinical Trial: Virtual Imaging-based Hepatic Venous Pressure Gradient (vHVPG) (CHESS-01)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Virtual Imaging-based Hepatic Venous Pressure Gradient for Assessment of Clinically Significant Portal Hypertension

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 Summary: 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.
Sponsor: Nanfang Hospital of Southern Medical University

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • vHVPG Numerical Correlation [ Time Frame: 1 day ]
    Correlation of the vHVPG numerical value with the HVPG numerical value


Original Secondary Outcome: Same as current

Information By: Nanfang Hospital of Southern Medical University

Dates:
Date Received: July 19, 2016
Date Started: August 2016
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017