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

Primary Purpose

Chronic Liver Disease

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intervention
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Liver Disease focused on measuring portal pressure, portosystemic pressure gradient, azygos blood flow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 18, 2015
Last Updated
August 19, 2019
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02530567
Brief Title
Non-invasive Evaluation of Portal Pressure by MRI
Acronym
ENIP
Official Title
Using MRI for a Non-invasive Evaluation of Portal Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
recruitment defect
Study Start Date
October 2015 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
Keywords
portal pressure, portosystemic pressure gradient, azygos blood flow

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intervention
Intervention Description
All patients performing the biopsy will have an MRI to carry out the necessary measures.
Primary Outcome Measure Information:
Title
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI.
Description
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 Outcome Measure Information:
Title
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.
Description
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
Title
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillipe OTAL, MD
Organizational Affiliation
UH TOULOUSE
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18328931
Citation
Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9.
Results Reference
background
PubMed Identifier
18462268
Citation
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.
Results Reference
background
PubMed Identifier
19724251
Citation
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.
Results Reference
background
PubMed Identifier
21274889
Citation
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.
Results Reference
background

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Non-invasive Evaluation of Portal Pressure by MRI

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