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

Hypertension, Portal Clinical Trial

— rHVPG  

Official title:

Development and Validation of a Radiomics Signature for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1701): a Prospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138915
• Other study ID #: CHESS1701
• Status: Completed
• Phase: N/A
• Start date: May 18, 2017
• Est. completion date: October 8, 2017

Study information

• Verified date: January 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: October 8, 2017
• Est. primary completion date: October 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal

Intervention

Procedure:
• HVPG measurement
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
• CTA
Radiomic features were extracted from CTA images.

Locations

Country	Name	City	State
China	302 Hospital of PLA	Beijing	Beijing
China	Beijing Shijitan Hospital	Beijing	Beijing
China	Beijing Youan Hospital	Beijing	Beijing
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Xingtai People's Hospital	Xingtai	Hebei

Sponsors (6)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Beijing 302 Hospital, Beijing Shijitan Hospital, Beijing YouAn Hospital, The Third Xiangya Hospital of Central South University, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. Erratum in: Hepatology. 2017 Jul;66(1):304. — View 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. — View 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 radiomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy of rHVPG	Diagnostic accuracy of rHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG=10mmHg)	1 day
Secondary	Diagnostic Performance of rHVPG	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of rHVPG when compared to HVPG as the reference standard (HVPG=10mmHg)	1 day
Secondary	rHVPG Numerical Correlation	Correlation of the rHVPG numerical value with the HVPG numerical value	1 day