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

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ClinicalTrials.gov Identifier: NCT02842697
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Beijing 302 Hospital
Beijing Shijitan Hospital
Information provided by (Responsible Party):
Xiaolong Qi, Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment Phase
Hypertension, Portal Procedure: HVPG measurement Procedure: CTA Procedure: Doppler ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension
Actual Study Start Date : August 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single arm study

Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG 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
Three-dimensional hepatic vein-portal vein model constructed with CTA images

Procedure: Doppler ultrasound
Portal vein velocity measured by Doppler ultrasound




Primary Outcome Measures :
  1. Diagnostic Accuracy of vHVPG [ Time Frame: 1 day ]
    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 :
  1. Diagnostic Performance of vHVPG [ Time Frame: 1 day ]
    Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of vHVPG when compared to HVPG as the reference standard (HVPG≥10mmHg)

  2. vHVPG Numerical Correlation [ Time Frame: 1 day ]
    Correlation of the vHVPG numerical value with the HVPG numerical value



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842697


Locations
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China, Beijing
Beijing 302 Hospital
Beijing, Beijing, China
Beijing Shijitan Hospital
Beijing, Beijing, China
China, Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Beijing 302 Hospital
Beijing Shijitan Hospital
Investigators
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Principal Investigator: Xiaolong Qi, M.D. Nanfang Hospital of Southern Medical University
Publications of Results:
Other Publications:
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Responsible Party: Xiaolong Qi, M.D., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02842697    
Other Study ID Numbers: CHESS1601
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xiaolong Qi, Nanfang Hospital of Southern Medical University:
clinically significant portal hypertension
hepatic venous pressure gradient
computed tomographic angiography
Additional relevant MeSH terms:
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Hypertension, Portal
Hypertension
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases