Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)
- Conditions
- Hypertension, Portal
- Interventions
- Procedure: HVPG measurementProcedure: CTA
- Registration Number
- NCT03138915
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 385
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm study HVPG measurement Patients will receive CTA, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement Single arm study CTA Patients will receive CTA, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement
- Primary Outcome Measures
Name Time Method Diagnostic Accuracy of rHVPG 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 Outcome Measures
Name Time Method rHVPG Numerical Correlation 1 day Correlation of the rHVPG numerical value with the HVPG numerical value
Diagnostic Performance of rHVPG 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)
Trial Locations
- Locations (6)
Beijing Youan Hospital
🇨🇳Beijing, Beijing, China
302 Hospital of PLA
🇨🇳Beijing, Beijing, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
Beijing Shijitan Hospital
🇨🇳Beijing, Beijing, China
Nanfang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China