Clinical trial NCT03138915: Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)
Official title: Development and Validation of a Radiomics Signature for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1701): a Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Portal
Keywords: clinically significant portal hypertension
hepatic venous pressure gradient
radiomics
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: The Third Xiangya Hospital of Central South University
name: Beijing YouAn Hospital
name: Xingtai People's Hospital
First posted: 2017-05-03
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of rHVPG
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic Performance of rHVPG
timeFrame: 1 day
measure: rHVPG Numerical Correlation
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xiaolong Qi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
citation: Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
citation: de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
citation: 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. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.
citation: Liu Y, Ning Z, Ormeci 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, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Ellik Z, Asiller OO, Liu Z, Teng G, Chen Y, Hou J, Li X, He X, Dong J, Tian J, Liang P, Ju S, Zhang Y, Qi X. Deep Convolutional Neural Network-Aided Detection of Portal Hypertension in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2998-3007.e5. doi: 10.1016/j.cgh.2020.03.034. Epub 2020 Mar 21.