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

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Hypertension, Portal

Treatments: Procedure: Doppler ultrasound; Procedure: HVPG measurement; Procedure: CTA

Study type: Interventional

Funder types: Other

Identifiers

NCT02842697

CHESS1601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Single arm study

Experimental group

Description:

Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement

Treatment:

Procedure: Doppler ultrasound

Procedure: CTA

Procedure: HVPG measurement