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

• Sponsor: Nanfang Hospital of Southern Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03138915
• Collaborator: Beijing 302 Hospital (Other), Beijing Shijitan Hospital, Capital Medical University (Other), The Third Xiangya Hospital of Central South University (Other), Beijing YouAn Hospital (Other), Xingtai People's Hospital (Other)
• Enrollment: 385
• Locations: 6
• Arm: 1
• Actual Duration (Months): 4.7
• Patients Per Site: 64.2
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Portal	Procedure: HVPG measurement; Procedure: CTA	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 385 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Development and Validation of a Radiomics Signature for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1701): a Prospective Multicenter Study
• Actual Study Start Date: May 18, 2017
• Actual Primary Completion Date: Oct 8, 2017
• Actual Study Completion Date: Oct 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single arm study Patients will receive CTA, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement	Procedure: HVPG measurement; HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.; Procedure: CTA; Radiomic features were extracted from CTA images.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

2. rHVPG Numerical Correlation [1 day]

   Correlation of the rHVPG numerical value with the HVPG numerical value

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	302 Hospital of PLA	Beijing	Beijing	China
2	Beijing Shijitan Hospital	Beijing	Beijing	China
3	Beijing Youan Hospital	Beijing	Beijing	China
4	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China
5	Xingtai People's Hospital	Xingtai	Hebei	China
6	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Xiaolong Qi, M.D, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Xiaolong Qi, M.D., Nanfang Hospital of Southern Medical University
• ClinicalTrials.gov Identifier: NCT03138915
• Other Study ID Numbers: CHESS1701
• First Posted: May 3, 2017
• Last Update Posted: Jan 8, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xiaolong Qi, M.D., Nanfang Hospital of Southern Medical University: clinically significant portal hypertension; hepatic venous pressure gradient; radiomics
• Additional relevant MeSH terms: Hypertension, Portal; Hypertension

Study Results

No Results Posted as of Jan 8, 2019