Primary Objective:Validate the accuracy of:· MR Flow mapping in measuring PPG in patients with GoreTex®-covered TIPS as compared to the gold standard, portography.· MRA for establishing TIPS patency as compared to Doppler US and using invasive…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy of MR flow mapping to measure PPG, using invasive pressure
measurements of PPG, portography, in patients with a GoreTex®-covered TIPS.
Accuracy and comparison of MR angiography, MR flow mapping and Doppler US to
detect shunt dysfunction of GoreTex®-covered TIPS using invasive portography as
gold standard.
Secondary outcome
o Patient acceptability with each technique.
o Interobserver agreement in analysis of the MRI data and Doppler US data.
Background summary
Patients with a transjugular intrahepatic portosystemic shunt (TIPS) have
portography or Doppler ultrasonography regularly (about once a year) as a
control for shunt dysfunction. Portography is the gold standard, but this
procedure is invasive and therefore burdensome for the patient. Doppler US is
difficult to perform and highly dependent on operator*s skill. Therefore, a
test is needed that is less invasive than portography and easier to perform and
interpret than Doppler US. CT angiography has proven to be accurate for this
purpose. This, however, requires ionizing radiation and iodinated contrast
agents.
MR flow mapping can measure flow volumes. With flow volumes within the stent
the porto-systemic pressure gradient (PPG) can be calculated by Poiseuille*s
Law Calculation (protocol page 4).
Vasovist is the first intravascular contrast agent approved for use with
Magnetic Resonance Angiography in the European Union. Vasovist is an optimal
contrast agent for detection of structural abnormalities, such as stenosis, in
the vasculature.
We propose that MR flow mapping can be used in measuring PPG and MRA (with
Vasovist) can be used as a screening device for shunt dysfunction.
Study objective
Primary Objective:
Validate the accuracy of:
· MR Flow mapping in measuring PPG in patients with GoreTex®-covered TIPS
as compared to the gold standard, portography.
· MRA for establishing TIPS patency as compared to Doppler US and using
invasive portography and portal venous pressure measurements as gold standard.
Secondary Objective:
Determine
· Patient acceptability with each technique.
· Interobserver variability in analysis of the MRI- and Doppler US data.
Study design
A validation study. Patients with a GoreTex®-covered TIPS will have MR flow
mapping and MRA with Vasovist, which will be compared with portography and
Doppler US.
Study burden and risks
Within the scope of this study patients with a Gore-Tex®-covered TIPS will have
an MRA and MR Flow mapping with Vasovist, in addition to the standard care
consisting of portography and Doppler US, which will be performed twice. The
risks of MRA and MR flow mapping with Vasovist are negligible.
We expect that this study will provide the foundation for the future
implementation of MR flow mapping with contrast in measuring PPG and of MRA as
screening device for shunt abnormalities, providing a less burdensome modality
to the entire patient population.
Dr. Molewaterplein 40
3015 GD
Nederland
Dr. Molewaterplein 40
3015 GD
Nederland
Listed location countries
Age
Inclusion criteria
Patients with a GoreTex®-covered TIPS
Age>18 years
Informed consent
Exclusion criteria
Age<18 years
Any contraindication to MRI:
- pacemaker
- cerebral aneurysm clip
- cochlear implant
- presence of metal/shrapnel in strategic locations such as the eye
- claustrophobia
- not being able to remain lying down for at least 45-60 minutes (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain)
Any contraindication to the administration of the contrast agent Vasovist
Severe renal impairment (clearance < 20 ml/min)
Hemodynamically unstable
Severe hepatic encephalopathy (grade III and IV)
Design
Recruitment
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 | NL18162.078.07 |