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Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601) (vHVPG)

Primary Purpose

Hypertension, Portal

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HVPG measurement
CTA
Doppler ultrasound
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, computed tomographic angiography

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 compensated 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 CTA within 14 days prior to hepatic vein catheterization
  • No hepatic-portal vein interventional therapy between the CTA 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

  • Beijing 302 Hospital
  • Beijing Shijitan Hospital
  • Nanfang Hospital, Southern Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement

Outcomes

Primary Outcome Measures

Diagnostic Accuracy of vHVPG
Diagnostic accuracy of vHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg)

Secondary Outcome Measures

Diagnostic Performance of vHVPG
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of vHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg)
vHVPG Numerical Correlation
Correlation of the vHVPG numerical value with the HVPG numerical value

Full Information

First Posted
July 19, 2016
Last Updated
January 4, 2019
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Beijing 302 Hospital, Beijing Shijitan Hospital, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02842697
Brief Title
Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601)
Acronym
vHVPG
Official Title
Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multi-center trial conducted at 1 Guangzhou and 2 Beijing centers designed to determine the diagnostic performance of virtual hepatic venous pressure gradient (vHVPG) (investigational technology) by anatomic computed tomographic angiography (CTA) for non-invasive assessment of the clinically significant portal hypertension (CSPH) in patients with compensated 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 trial conducted at 1 Guangzhou (Nanfang Hospital) and 2 Beijing (Beijing 302 Hospital, Beijing Shijitan Hospital) centers designed to determine the diagnostic performance of vHVPG (investigational technology) by anatomic CTA for non-invasive assessment of the CSPH in patients with compensated cirrhosis. Direct 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, computed tomographic angiography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG 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
Three-dimensional hepatic vein-portal vein model constructed with CTA images
Intervention Type
Procedure
Intervention Name(s)
Doppler ultrasound
Intervention Description
Portal vein velocity measured by Doppler ultrasound
Primary Outcome Measure Information:
Title
Diagnostic Accuracy of vHVPG
Description
Diagnostic accuracy of vHVPG 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 vHVPG
Description
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of vHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg)
Time Frame
1 day
Title
vHVPG Numerical Correlation
Description
Correlation of the vHVPG 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 compensated 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 CTA within 14 days prior to hepatic vein catheterization No hepatic-portal vein interventional therapy between the CTA 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
Beijing 302 Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Shijitan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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
24679495
Citation
de Franchis R, Dell'Era A. Invasive and noninvasive methods to diagnose portal hypertension and esophageal varices. Clin Liver Dis. 2014 May;18(2):293-302. doi: 10.1016/j.cld.2013.12.002. Epub 2014 Feb 25.
Results Reference
background
PubMed Identifier
23363263
Citation
Berzigotti A, Seijo S, Reverter E, Bosch J. Assessing portal hypertension in liver diseases. Expert Rev Gastroenterol Hepatol. 2013 Feb;7(2):141-55. doi: 10.1586/egh.12.83.
Results Reference
background
PubMed Identifier
22922562
Citation
Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274.
Results Reference
background
PubMed Identifier
25398771
Citation
Qi X, Li Z, Huang J, Zhu Y, Liu H, Zhou F, Liu C, Xiao C, Dong J, Zhao Y, Xu M, Xing S, Xu W, Yang C. Virtual portal pressure gradient from anatomic CT angiography. Gut. 2015 Jun;64(6):1004-5. doi: 10.1136/gutjnl-2014-308543. Epub 2014 Nov 14. No abstract available.
Results Reference
background
PubMed Identifier
30457484
Citation
Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.
Results Reference
result

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Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601)

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