Virtual Imaging-based Early Portal Pressure Gradient (vePPG) (CHESS1702)

Summary

Portal pressure gradient (PPG) above 12 mmHg after transjugular intrahepatic portosystemic shunt (TIPS) increases the risk of portal hypertension complications. Currently, a PPG reduction \<12 mmHg after TIPS is the most consistent threshold associated with almost complete protection from variceal bleeding and ascites. However, the measurement of PPG requires an invasive procedure. A recent study investigated the variations in PPG measurements collected at different time points after placement of TIPS and demonstrated that a time point of at least 24 hours after which PPG values were best maintained (early PPG). It is of great clinical value to propose that an immediate PPG measurement fail to accurately identify the risk of decompensated event. And early PPG would change the decision making for re-intervention or not. However, the repeated invasive examination is extremely difficult to follow in clinical practice worldwide. The prospective multicenter trial aims to assess the diagnostic performance of a virtual imaging-based early portal pressure gradient (vePPG) (investigational technology) from CT angiography and Doppler ultrasound with invasive early PPG measurement as reference. The study participants with portal hypertension will be prospectively recruited at 10 high-volume liver centers in China.

Conditions

• Hypertension, Portal

Interventions

PROCEDURE

Invasive PPG

Invasive PPG obtained by means of catheterization.

Sponsors & Collaborators

• Beijing Shijitan Hospital, Capital Medical University

  collaborator OTHER

• Beijing 302 Hospital

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Xingtai People's Hospital

  collaborator OTHER

• Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University

  collaborator UNKNOWN

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• PLA Army General Hospital

  collaborator UNKNOWN

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Fuquan Liu, MD · Beijing Shijitan Hospital, Capital Medical University

• Zhiwei Li, MD · Beijing 302 Hospital

• Xiaolong Qi, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-24

Primary Completion

2019-01-31

Completion

2019-01-31

Countries

• China

Study Locations