Chronic Liver DiseaseENIPNCT02530567
Non-invasive Evaluation of Portal Pressure by MRI
A study testing Intervention in people with Chronic Liver Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspicion of chronic liver disease
- Indication to perform a liver biopsy transjugular
- Patient able to consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using MRI for a Non-invasive Evaluation of Portal Pressure
The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI.
Read the 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
- Conditions
- Chronic Liver Disease
- Being tested
- Intervention
- Keywords
- portal pressure, portosystemic pressure gradient, azygos blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionProcedure or surgery
All patients performing the biopsy will have an MRI to carry out the necessary measures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (2)
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.
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2019
- Study completionJul 2019
Why it stopped: recruitment defect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phillipe OTAL, MD, Principal investigator, UH TOULOUSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530567
- Sponsor's protocol ID
- RC31/14/7318
- Other IDs
- University Hospital Toulouse
- Acronym
- ENIP
- Status last verified
- Aug 2019
- First submitted
- 18 Aug 2015
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9.
PubMed 18328931Garcia-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.
PubMed 18462268Bosch 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.
PubMed 19724251Thabut 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.
PubMed 21274889
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using MRI for a Non-invasive Evaluation of Portal Pressure
- ClinicalTrials.gov ID
- NCT02530567
- Acronym / sponsor ID
- ENIP / RC31/14/7318
- Conditions
- Chronic Liver Disease
- Keywords
- portal pressure, portosystemic pressure gradient, azygos blood flow
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment defect
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 21 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suspicion of chronic liver disease
- Indication to perform a liver biopsy transjugular
- Patient able to consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAll patients performing the biopsy will have an MRI to carry out the necessary measures. | Procedure or surgery | Intervention |
Primary outcome
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI.
Time frame: 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.
2 secondary outcomes
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and aortic flow measured by MRI.
Time frame: 1 week
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and throughput inferior vena measured by MRI.
Time frame: 1 week
Results and safety
The study was stopped early (reason given: recruitment defect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Background: PubMed 18328931Schuppan D, Afdhal NH. Liver cirrhosis. Lancet. 2008 Mar 8;371(9615):838-51. doi: 10.1016/S0140-6736(08)60383-9.
- Background: PubMed 18462268Garcia-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.
- Background: PubMed 19724251Bosch 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.
- Background: PubMed 21274889Thabut 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillipe OTAL, MD principal investigator
UH TOULOUSE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Chronic Liver Disease, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment defect). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between portosystemic pressure gradient measured by catheterization of the hepatic veins transjugular and azygos flow measured by MRI. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530567, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.