Clinical Trial: Radiomics-based Hepatic Venous Pressure Gradient (rHVPG) (CHESS-02)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Radiomics-based Hepatic Venous Pressure Gradient (rHVPG) for Clinically Significant Portal Hypertension

Brief Summary: This is a prospective, multi-center trial conducted at 10 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with 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 10 high-volume liver centers (302 Hospital of PLA; Beijing Shijitan Hospital; Third Affiliated Hospital, Sun Yat-Sen University; First Affiliated Hospital, Sun Yat-Sen University; Beijing Ditan Hospital; The Third Xiangya Hospital of Central South University; PLA Army General Hospital; Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University; Xingtai People's Hospital) in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with 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.
Sponsor: Nanfang Hospital of Southern Medical University

Current Primary Outcome: Diagnostic Accuracy of rHVPG [ Time Frame: 1 day ]

Diagnostic accuracy of rHVPG 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 rHVPG [ Time Frame: 1 day ]
    Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of rHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg)
  • rHVPG Numerical Correlation [ Time Frame: 1 day ]
    Correlation of the rHVPG numerical value with the HVPG numerical value


Original Secondary Outcome: Same as current

Information By: Nanfang Hospital of Southern Medical University

Dates:
Date Received: April 29, 2017
Date Started: May 18, 2017
Date Completion: October 2017
Last Updated: May 18, 2017
Last Verified: May 2017