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Completed

NCT Number: NCT03138915

Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)

This is a prospective, multi-center diagnostic trial conducted at 5 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

302 Hospital of PLA, Beijing, Beijing Municipality, China

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About this study

This is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers (302 Hospital of PLA; Beijing Shijitan Hospital; The Third Xiangya Hospital of Central South University; Beijing Youan Hospital; 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.

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 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 CT within 14 days prior to hepatic vein catheterization
  • No hepatic-portal vein interventional therapy between the CT 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

Radiomic features were extracted from CTA images.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. rHVPG Numerical Correlation

    Time frame: 1 day

    Correlation of the rHVPG 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
  • Beijing YouAn Hospital
  • The Third Xiangya Hospital of Central South University
  • Xingtai People's Hospital

Registry information

Official study title

Development and Validation of a Radiomics Signature for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1701): a Prospective Multicenter Study

Acronym: rHVPG

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 3, 2017
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.

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