The study aims to determine the feasibility and diagnostic accuracy of quantitative Magnetic Resonance Imaging (MRI) techniques for determining the presence of portal hypertension in patients with severe liver disease. The secondary objectives are…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Vascular therapeutic procedures
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• The diagnostic accuracy of TMRE for assessing portal hypertension severity.
Secondary outcome
• Correlation of TMRE results (stiffness and viscosity) with HVPG pressure
gradient measurements in patients with portal hypertension.
• Correlation of TMRE results with US elastography measurements.
• Correlation of TMRE results with ASL perfusion data.
• Characterisation of TMRE in normalization of portal hypertension after
medicinal or endovascular treatment.
• The feasibility of novel synthetic MRI (SyMRI).
Background summary
Hepatic vein pressure gradient (HVPG) measurements are currently the reference
standard for evaluating the portal pressure. In clinical practice, however,
other non-invasive methods with low diagnostic accuracy are used. More reliable
non-invasive imaging techniques for diagnosis of portal hypertension and
follow-up of portal pressure in time are needed.
Study objective
The study aims to determine the feasibility and diagnostic accuracy of
quantitative Magnetic Resonance Imaging (MRI) techniques for determining the
presence of portal hypertension in patients with severe liver disease. The
secondary objectives are to correlate tomoelastography results (stiffness and
viscosity) with elastography measurements, to correlate tomoelastography
results with HVPG pressure gradient measurements, and to investigate if
tomoelastography can assess normalization of portal hypertension after
medicinal or endovascular (transjugular intrahepatic portosystemic shunt
(TIPS)) treatment.
Study design
This study is a single centre, prospective study to determine the feasibility
and diagnostic accuracy of quantitative MRI techniques in 20 healthy
volunteers, 40 patients with liver cirrhosis and known to have portal
hypertension of which 20 patients with moderate portal hypertension and 20
patients with severe portal hypertension.
Study burden and risks
The risks and burden associated with participating in this study are very low.
Patients and healthy volunteers will undergo an additional MRI investigation as
part of this study. As there is no use of radiation, there is no subsequent
risk of exposure to radiation during an MRI procedure. Subjects with implanted
medical devices will not receive an MRI exam unless the implanted medical
device has been positively identified as MR Safe or MR Conditional. An MR
Conditional device will only be considered safe if the MR environment matches
its conditions for safe use. There is no direct benefit from this study.
Hanzeplein 1 Postbus 30 001
the Netherlands Groningen
NL
Hanzeplein 1 Postbus 30 001
the Netherlands Groningen
NL
Listed location countries
Age
Inclusion criteria
Patients with liver disease:
• Patients of more than 18 years of age
• Written informed consent
• Patients with clinically proven portal hypertension due to chronic liver
disease, either moderate (history of oesophageal varices grade 2/3 without use
of beta-blockers as pharmaceutical treatment) or severe (recurrent oesophageal
variceal bleeding, therapy-resistant ascites)
Healthy controls:
• Patients of more than 18 years of age
• Written informed consent
• No known liver disease by means of liver function test/ultrasound
Exclusion criteria
- Absolute contraindications to MR imaging
- Hepatocellular carcinoma or liver metastases
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74470.042.23 |