NCT02530567

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

August 18, 2015

Last Update Submit

August 19, 2019

Conditions

Chronic Liver Disease

Keywords

portal pressureportosystemic pressure gradientazygos blood flow

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.

    1 week

  • Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.

    1 week

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

InterventionPROCEDURE

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Toulouse

Toulouse, 31059, France

Location

Related Publications (4)

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

    PMID: 18328931BACKGROUND

  • 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.

    PMID: 18462268BACKGROUND

  • 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.

    PMID: 19724251BACKGROUND

  • 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.

    PMID: 21274889BACKGROUND

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Phillipe OTAL, MD

    UH TOULOUSE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 21, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations

FR(1)