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TerminatedNCT02530567ENIPUpdated Aug 21, 2019

Non-invasive Evaluation of Portal Pressure by MRI

An interventional study of Intervention in Chronic Liver Disease, sponsored by University Hospital, Toulouse. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science

Why this study was terminated
recruitment defect
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI.

Read the detailed description

All patients will benefit from:

  • Pressure gradient measurement portosystemic
  • MRI measurement of azygos flow, aortic, portals, spleen and lower cellar
  • Liver biopsy
  • Laboratory tests
02

Conditions studied

  • Chronic Liver Disease

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Keywords

  • portal pressure
  • portosystemic pressure gradient
  • azygos blood flow
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Suspicion of chronic liver disease
  • Indication to perform a liver biopsy transjugular
  • Patient able to consent

Exclusion criteria

Exclusion Criteria:

  • contraindication to MRI:
  • Holders of a pacemaker or a defibrillator, an implanted material activated by electrical, magnetic or mechanical
  • Holders of hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants
  • claustrophobic
  • Severe hepatic encephalopathy
  • Inability to MRI in the week surrounding the first jugular
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Intervention

    The measurement of portosystemic pressure gradient will be performed before liver biopsy. Then liver biopsy is performed. The MRI was performed on the day of biopsy or within one week around the completion of the biopsy. The MRI machine used is the Siemens 3T.

    Procedure: Intervention

Interventions

  • ProcedureIntervention

    All patients performing the biopsy will have an MRI to carry out the necessary measures.

06

What researchers measure

Primary outcomes

  1. Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI.

    MRI and catheterization will be performed the same week. For the azygos blood flow (by MRI), measures will be repeated 5 times. Speed of extraction and the rate on the post processing console will be made with a double reading. For the measurement of portal pressure by catheterization, will be performed measurements of occluded hepatic vein pressure and free hepatic vein. They will be repeated 3 times each. These measures will be carried out to calculate the portosystemic pressure gradient. The flow rate and gradient measurements will be performed blindly to the other.

    Time frame: 1 week

Secondary outcomes

  1. Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.

    This outcome is different of primary outcome because the Measurement of azygos blood flow (MRI) is repeated on a strictly perpendicular section to the vessel facing the T4-T5 disk and the extraction speed rate and on post processing console is made by double reading. Measuring portal pressure by catheterization. Measurements of occluded hepatic vein pressure and free hepatic vein and will be repeated 3 times each. Flow measurements and gradient will be carried out blind to each other by the radiologist and the hepatologist.

    Time frame: 1 week

  2. Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.

    Measurement of azygos blood flow (MRI) Repeated Measure 5 times on a strictly perpendicular cut to the vessel immediately after anastomosis of the hepatic veins to the inferior vena cava and Extraction speed and flow on post processing console with double reading. Measurement of portal pressure by catheterization It will be defined by the measures of occluded hepatic vein pressure and free hepatic vein and measurements will be repeated 3 times each. The flow rate and gradient measurements will be performed blindly to the other.

    Time frame: 1 week

07

Study locations

1 site
  • UH Toulouse
    Toulouse, 31059, France
08

References and documents

Publications

  • Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9. PubMed 18328931 ↗
  • Garcia-Pagan JC, De Gottardi A, Bosch J. Review article: the modern management of portal hypertension--primary and secondary prophylaxis of variceal bleeding in cirrhotic patients. Aliment Pharmacol Ther. 2008 Jul;28(2):178-86. doi: 10.1111/j.1365-2036.2008.03729.x. Epub 2008 May 2. PubMed 18462268 ↗
  • Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1. PubMed 19724251 ↗
  • Thabut D, Moreau R, Lebrec D. Noninvasive assessment of portal hypertension in patients with cirrhosis. Hepatology. 2011 Feb;53(2):683-94. doi: 10.1002/hep.24129. PubMed 21274889 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02530567
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Aug 21, 2015
Start date
Oct 2015
Primary completion
Jul 2019
Completion
Jul 2019
Last update
Aug 21, 2019

Study contacts

Phillipe OTAL, MD
principal investigator · UH TOULOUSE

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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