Non-invasive Evaluation of Portal Pressure by MRI

Chronic Liver Disease Clinical Trial

— ENIP  

Official title:

Using MRI for a Non-invasive Evaluation of Portal Pressure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02530567
• Other study ID #: RC31/14/7318
• Secondary ID: University Hospi
• Status: Terminated
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

Procedure:
• Intervention
All patients performing the biopsy will have an MRI to carry out the necessary measures.

Locations

Country	Name	City	State
France	UH Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

Bosch J, Abraldes JG, Berzigotti A, García-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. Review. — View 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. Review. — View Citation

Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week