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

Not Applicable

Completed

• Conditions: Hypertension, Portal
• Interventions: Procedure: HVPG measurement; Procedure: CTA; Procedure: Doppler ultrasound

• Registration Number: NCT02842697
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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 Description

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.

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-25
• Study Start: 2016-08
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study	CTA	Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement
Single arm study	Doppler ultrasound	Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement
Single arm study	HVPG measurement	Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of vHVPG	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 Outcome Measures

Name	Time	Method
Diagnostic Performance of vHVPG	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	1 day	Correlation of the vHVPG numerical value with the HVPG numerical value

Trial Locations

Locations (3)

Beijing 302 Hospital; 🇨🇳 Beijing, Beijing, China

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China