Hypertension, PortalvHVPGNCT02842697
Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601)
A study testing HVPG measurement, CTA and Doppler ultrasound in people with Hypertension, Portal, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Portal
- What is being tested?
- HVPG measurement, CTA and Doppler ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesChina
- Study dates
- Aug 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing 302 Hospital
Beijing, Beijing Municipality
Beijing Shijitan Hospital
Beijing, Beijing Municipality
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
About this study
Official title: Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension
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.
Read the 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.
- Conditions
- Hypertension, Portal
- Being tested
- HVPG measurement, CTA, Doppler ultrasound
- Keywords
- clinically significant portal hypertension, hepatic venous pressure gradient, computed tomographic angiography
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HVPG measurementProcedure or surgery
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter
CTAProcedure or surgery
Three-dimensional hepatic vein-portal vein model constructed with CTA images
Doppler ultrasoundProcedure or surgery
Portal vein velocity measured by Doppler ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | Patients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol.
Intervention: Procedure: HVPG measurement Receives: Procedure: HVPG measurement; Procedure: CTA; Procedure: Doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 day
Secondary outcomes (2)
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)
Measured: 1 day
vHVPG Numerical Correlation
Correlation of the vHVPG numerical value with the HVPG numerical value
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PortalStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, Beijing Shijitan Hospital, Capital Medical University
- Responsible party
- Principal investigator, Xiaolong Qi, Nanfang Hospital, Southern Medical University
- Investigators
- Xiaolong Qi, M.D., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842697
- Sponsor's protocol ID
- CHESS1601
- Acronym
- vHVPG
- Status last verified
- Jan 2019
- First submitted
- 19 Jul 2016
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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. No abstract available.
PubMed 26047908de 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.
PubMed 24679495Berzigotti 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.
PubMed 23363263Min 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.
PubMed 22922562Qi 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.
PubMed 25398771Qi 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.
PubMed 30457484
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension
- ClinicalTrials.gov ID
- NCT02842697
- Acronym / sponsor ID
- vHVPG / CHESS1601
- Conditions
- Hypertension, Portal
- Keywords
- clinically significant portal hypertension, hepatic venous pressure gradient, computed tomographic angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, Beijing Shijitan Hospital, Capital Medical University
- Study start
- Aug 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Procedure: HVPG measurement, Procedure: CTA, Procedure: Doppler ultrasoundPatients will receive CTA, Doppler ultrasound, HVPG measurement, and vHVPG per protocol. Intervention: Procedure: HVPG measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HVPG measurementHVPG obtained by means of catheterization of a hepatic vein with a balloon catheter | Procedure or surgery | Single arm study |
| CTAThree-dimensional hepatic vein-portal vein model constructed with CTA images | Procedure or surgery | Single arm study |
| Doppler ultrasoundPortal vein velocity measured by Doppler ultrasound | Procedure or surgery | Single arm study |
Primary outcome
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)
2 secondary outcomes
Diagnostic Performance of vHVPG
Time frame: 1 day
vHVPG Numerical Correlation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Background: PubMed 26047908de 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.
- Background: PubMed 24679495de 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.
- Background: PubMed 23363263Berzigotti 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.
- Background: PubMed 22922562Min 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.
- Background: PubMed 25398771Qi 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 publication: PubMed 30457484Qi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaolong Qi, M.D. principal investigator
Nanfang Hospital, Southern Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HVPG measurement, CTA and Doppler ultrasound in people with Hypertension, Portal, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of vHVPG (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02842697, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.