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

Primary Purpose

Hypertension, Portal

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HVPG measurement
CTA
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension, Portal focused on measuring clinically significant portal hypertension, hepatic venous pressure gradient, radiomics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

Patients will receive CTA, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
rHVPG Numerical Correlation
Correlation of the rHVPG numerical value with the HVPG numerical value

Full Information

First Posted
April 29, 2017
Last Updated
January 4, 2019
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Beijing 302 Hospital, Beijing Shijitan Hospital, Capital Medical University, The Third Xiangya Hospital of Central South University, Beijing YouAn Hospital, Xingtai People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03138915
Brief Title
Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)
Acronym
rHVPG
Official Title
Development and Validation of a Radiomics Signature for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1701): a Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 18, 2017 (Actual)
Primary Completion Date
October 8, 2017 (Actual)
Study Completion Date
October 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Beijing 302 Hospital, Beijing Shijitan Hospital, Capital Medical University, The Third Xiangya Hospital of Central South University, Beijing YouAn Hospital, Xingtai People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Portal
Keywords
clinically significant portal hypertension, hepatic venous pressure gradient, radiomics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
Patients will receive CTA, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement
Intervention Type
Procedure
Intervention Name(s)
HVPG measurement
Intervention Description
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
Intervention Type
Procedure
Intervention Name(s)
CTA
Intervention Description
Radiomic features were extracted from CTA images.
Primary Outcome Measure Information:
Title
Diagnostic Accuracy of rHVPG
Description
Diagnostic accuracy of rHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Diagnostic Performance of rHVPG
Description
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of rHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg)
Time Frame
1 day
Title
rHVPG Numerical Correlation
Description
Correlation of the rHVPG numerical value with the HVPG numerical value
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolong Qi, M.D
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
302 Hospital of PLA
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Youan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Xingtai People's Hospital
City
Xingtai
State/Province
Hebei
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26579733
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.
Results Reference
background
PubMed Identifier
27786365
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. Erratum In: Hepatology. 2017 Jul;66(1):304.
Results Reference
background
PubMed Identifier
26047908
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.
Results Reference
background
PubMed Identifier
30268833
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.
Results Reference
result
PubMed Identifier
32205218
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.
Results Reference
derived

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

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