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

Conditions

Hypertension, Portal

Keywords

Portal pressure gradient, Transjugular intrahepatic portosystemic shunt, Virtual imaging-based portal pressure gradient

Brief 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.

Detailed description

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 (Beijing Shijitan Hospital; 302 Hospital of PLA; Nanfang Hospital, Southern Medical University; The Third Xiangya Hospital of Central South University; Xingtai People's Hospital; Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University; First Affiliated Hospital, Sun Yat-Sen University; Beijing Ditan Hospital; PLA Army General Hospital; Third Affiliated Hospital, Sun Yat-Sen University) in China.

Related papers

No related papers found yet.

Interventions

PROCEDUREInvasive PPG

Invasive PPG obtained by means of catheterization.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

Inclusion criteria

* Patients providing written informed consent * Patients with portal hypertension and received the placement of TIPS * Patients with invasive immediate PPG and early PPG measurement * Has undergone \> 64 multi-detector row CT angiography and Doppler ultrasound within 3 days prior to invasive early PPG measurement

Exclusion criteria

* Any severe adverse events after TIPS placement * Inability to adhere to study procedures * 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

Design outcomes

Primary

Measure	Time frame	Description
vePPG Numerical Correlation	1 day	Correlation of vePPG numerical value with early PPG numerical value

Secondary

Measure	Time frame	Description
Immediate PPG Numerical Correlation	7 days	Correlation of immediate PPG numerical value with early PPG numerical value
Diagnostic Performance of vePPG	1 day	Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of vePPG to determine re-intervention or not when compared to invasive early PPG as reference (PPG≥12mmHg)

Countries

China

Outcome results

None listed