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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension, Portal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm study

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

Intervention: Procedure: HVPG measurement

Group Type EXPERIMENTAL

HVPG measurement

Intervention Type PROCEDURE

HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter

CTA

Intervention Type PROCEDURE

Three-dimensional hepatic vein-portal vein model constructed with CTA images

Doppler ultrasound

Intervention Type PROCEDURE

Portal vein velocity measured by Doppler ultrasound

Interventions

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HVPG measurement

HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter

Intervention Type PROCEDURE

CTA

Three-dimensional hepatic vein-portal vein model constructed with CTA images

Intervention Type PROCEDURE

Doppler ultrasound

Portal vein velocity measured by Doppler ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No