Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)

Conditions

Hypertension, Portal

Keywords

clinically significant portal hypertension, hepatic venous pressure gradient, radiomics

Brief summary

This is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with 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 diagnostic trial conducted at 5 high-volume liver centers (302 Hospital of PLA; Beijing Shijitan Hospital; The Third Xiangya Hospital of Central South University; Beijing Youan Hospital; Xingtai People's Hospital) in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with 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.

Chengyan Wang, Yifei Huang, Changchun Liu, Fuquan Liu, Xumei Hu et al. (13 authors)

Radiology2023-01-3123 citations

10.1148/radiol.221648

Deep Convolutional Neural Network-Aided Detection of Portal Hypertension in Patients With Cirrhosis.

Liu Y, Ning Z, Örmeci N, An W, Yu Q, Han K, Huang Y, Liu D, Liu F, Li Z, Ding H, Luo H, Zuo C, Liu C, Wang J, Zhang C, Ji J, Wang W, Wang Z, Wang W, Yuan M, Li L, Zhao Z, Wang G, Li M, Liu Q, Lei J, Liu C, Tang T, Akçalar S, Çelebioğlu E, Üstüner E, Bilgiç S, Ellik Z, Asiller ÖÖ, Liu Z, Teng G, Chen Y, Hou J, Li X, He X, Dong J, Tian J, Liang P, Ju S, Zhang Y, Qi X.

2020-03-2141 citations

10.1016/j.cgh.2020.03.034

Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study.

Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X.

2018-09-2762 citations

10.1016/j.ebiom.2018.09.023

Interventions

PROCEDUREHVPG measurement

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

PROCEDURECTA

Radiomic features were extracted from CTA images.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Age \>18 years * Patients providing written informed consent * Patients with 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 CT within 14 days prior to hepatic vein catheterization * No hepatic-portal vein interventional therapy between the CT 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

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic Accuracy of rHVPG	1 day	Diagnostic accuracy of rHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg)

Secondary

Measure	Time frame	Description
Diagnostic Performance of rHVPG	1 day	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of rHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg)
rHVPG Numerical Correlation	1 day	Correlation of the rHVPG numerical value with the HVPG numerical value

Countries

China

Outcome results

None listed