Non-invasive Evaluation of Portal Pressure by MRI

NCT ID: NCT02530567

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-07-31

Brief Summary

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

Detailed Description

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All patients will benefit from:

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

Conditions

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Chronic Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention

Intervention Type PROCEDURE

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

Interventions

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Intervention

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Phillipe OTAL, MD

Role: PRINCIPAL_INVESTIGATOR

UH TOULOUSE

Locations

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UH Toulouse

Toulouse, , France

Site Status

Countries

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France

References

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

Reference Type BACKGROUND
PMID: 18328931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18462268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19724251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21274889 (View on PubMed)

Other Identifiers

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University Hospital Toulouse

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC31/14/7318

Identifier Type: -

Identifier Source: org_study_id

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