Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601)
vHVPG
1 other identifier
interventional
102
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
July 25, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJanuary 8, 2019
January 1, 2019
8 months
July 19, 2016
January 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
1 day
Secondary Outcomes (2)
Diagnostic Performance of vHVPG
1 day
vHVPG Numerical Correlation
1 day
Study Arms (1)
Single arm study
EXPERIMENTALPatients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement
Interventions
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter
Three-dimensional hepatic vein-portal vein model constructed with CTA images
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Beijing 302 Hospital
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital
Beijing, Beijing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Related Publications (6)
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.
PMID: 26047908BACKGROUNDde 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.
PMID: 24679495BACKGROUNDBerzigotti 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.
PMID: 23363263BACKGROUNDMin 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.
PMID: 22922562BACKGROUNDQi 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.
PMID: 25398771BACKGROUNDQi 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.
PMID: 30457484RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaolong Qi, M.D.
Nanfang Hospital, Southern Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
July 19, 2016
First Posted
July 25, 2016
Study Start
August 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
January 8, 2019
Record last verified: 2019-01