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Non-invasive Evaluation of Portal Pressure by MRI (ENIP)

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ClinicalTrials.gov Identifier: NCT02530567
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Chronic Liver Disease Procedure: Intervention

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Using MRI for a Non-invasive Evaluation of Portal Pressure
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2018
Arms and Interventions

Arm Intervention/treatment
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
All patients performing the biopsy will have an MRI to carry out the necessary measures.


Outcome Measures

Primary Outcome Measures :
  1. Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI. [ Time Frame: 1 week ]

    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.



Secondary Outcome Measures :
  1. Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI. [ Time Frame: 1 week ]

    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.


  2. Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI. [ Time Frame: 1 week ]

    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.



Eligibility Criteria

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

Inclusion Criteria:

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

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
Contacts and Locations

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): NCT02530567


Contacts
Contact: Phillipe OTAL, MD 05 61 32 28 81/51 ext +33 otal.p@chu-toulouse.fr
Contact: Marianne LESCOUZERES 05 61 77 72 08 ext +33 lescouzeres.m@chu-toulouse.fr

Locations
France
UH Toulouse Recruiting
Toulouse, France, 31059
Contact: Philippe OTAL, MD    05 61 32 28 81/51 ext +33    otal.p@chu-toulouse.fr   
Contact: Olivier MEYRIGNAC, MD       meyrignac.o@chu-toulouse.fr   
Principal Investigator: Philippe OTAL, MD         
Sub-Investigator: Jean-Marie PERON, MD         
Sub-Investigator: Jean-Pierre VINEL, MD         
Sub-Investigator: Christophe BUREAU, MD         
Sub-Investigator: Maeva GUILLAUME, MD         
Sub-Investigator: Laurent ALRIC, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Phillipe OTAL, MD UH TOULOUSE
More Information