The primary objective is to develop and validate non-invasive portal pressure measurement by MRI in patients with end-stage liverdisease (ESLD).
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of the study is to compare non-invasive PH measurement by 4D flow MRI
and CFD modelling with HVPG measurements
using the transjugular approach in patients with end-stage liver disease
screened for OLT.
Secondary outcome
Secondary objectives are cost effectiveness, safety, feasibility and efficacy
of 4D flow MRI and CFD modelling.
Background summary
Portal hypertension (PH) is a spectrum of complications of end-stage liver
disease (ESLD) and cirrhosis, with severe manifestations including ascites and
gastroesophageal varices. It is therefore important that timely and easily
diagnosing PH has relevant prognostic and therapeutic implications. The current
gold standard to evaluate PH is by hepatic vein catherization using the
transjugular approach, and measuring the hepatic venous pressure gradients
(HVPG).
Time-resolved, three-dimensional, three-directional velocity-encoded MRI, also
termed four-dimensional (4D) flow MRI, has been shown superior accuracy over
conventional two-dimensional (2D) phase-contrast MRI, in particular for
quantification of regurgitant volumes and severity of cardiac shunts. Recently,
we developed new imaging methods based on 4D flow MRI for visualization of the
vasculature of the abdominal blood flow circulation including the portal vein.
Using our newly developed computation fluid dynamics (CFD) model we could
determine the absolute local blood pressure in the portal vein. Preliminary
data in healthy volunteers seem promising, however, data in patients with ESLD
including the correlation with invasively measured HVPG are lacking.
Study objective
The primary objective is to develop and validate non-invasive portal pressure
measurement by MRI in patients with end-stage liver
disease (ESLD).
Study design
In 50 adult patients with ESLD, submitted for liver transplantation (LT)
screening, HVPG measurements using the transjugular
approach according to the standard LT screening protocol, will be extended by
4D flow MRI measurements.
Study burden and risks
Patients will undergo a single non-invasive MRI-examination of one hour long
after a six hour period of fasting. The risks associated
with non-invasive MRI examinations is neglectable.
Albinusdreef 2
Leiden 2223ZA
NL
Albinusdreef 2
Leiden 2223ZA
NL
Listed location countries
Age
Inclusion criteria
- Eligable for liver transplantation (LT) screening
- Age >= 18 years and <= 75 (since >75 is a contraindication for LT)
- Written informed consent
Exclusion criteria
- Exclusion criteria for MRI (claustrophobia, pacemaker, metal implants, etc.)
- A psychiatric, addictive or any other disorder that compromises the subjects
ability to understand the study content and to give written informed consent
for participation in the study
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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 | NL85208.058.23 |