Non-invasive Evaluation of Portal Pressure by MRI

Not Applicable

Terminated

• Conditions: Chronic Liver Disease
• Interventions: Procedure: Intervention

• Registration Number: NCT02530567
• Lead Sponsor: University Hospital, Toulouse

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

Study Timeline

• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-20
• Study First Posted: 2015-08-21
• Study Start: 2015-10
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

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

Name	Time	Method
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.	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.
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.	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.

Trial Locations

Locations (1)

UH Toulouse; 🇫🇷 Toulouse, France