To assess whether MRI Primovist could replace 99mTc-mebrofenin HBS as a preoperative functional liver assessment in addition to CT-volumetry in predicting PHLF in patients with resectable pCCA who require a major liver resection.
ID
Source
Brief title
Condition
- Bile duct disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• To assess whether MRI Primovist could replace 99mTc-mebrefenin HBS as a
preoperative functional liver assessment in addition to CT-volumetry in
predicting PHLF in patients with resectable pCCA who require a major liver
resection.
Secondary outcome
• Define cut-off values of FLR for safe liver resection based on combined
MRI-based functional and CT-based volumetric and functional (99mTc-mebrefenin
HBS) measurements.
• Determine 90-day mortality.
• Occurrence of liver failure grade B or C according to the ISGLS criteria.
• Major postoperative complications (Clavien-Dindo >=3).
For patients undergoing PVE:
• Change in Primovist-based function of the future liver remnant (FLR), before
and after PVE.
• Comparison of change of Primovist-based function of the future FLR with
change in volume on CT, before and after PVE.
• Major complications attributable to PVE (Clavien-Dindo >=3).
• Comparison of findings with MRI based extracellular volume (ECV) measurements
of the spleen before and after PVE performed with post-processing tools.
• Prediction of volume and functional increase of the FLR, based on imaging
findings before PVE (including local segmental residual bile obstruction after
drainage, liver volumetry and Primovist-based function of the FLR).
Background summary
90-day mortality after (extended) hemihepatectomy for perihilar
cholangiocarcinoma (pCCA) is more than 10% in most Western centers. The
majority of patients die as a consequence of posthepatectomy liver failure
(PHLF). Portal vein embolization (PVE) was introduced to preoperatively enhance
the future liver remnant (i.e. the part of the liver that remains in the
patient after a liver resection). Postoperative liver failure and mortality are
reduced when PVE increases the size of the future liver remnant. However, liver
volume does not necessarily correlate with liver function. Another risk factor
for PHLF is impaired liver function. Primovist enhanced Magnetic Resonance
Imaging (MRI) is a quantitative functional assessment of the liver and has
shown potential in assessing the risk of PHLF after liver resection.
Study objective
To assess whether MRI Primovist could replace 99mTc-mebrofenin HBS as a
preoperative functional liver assessment in addition to CT-volumetry in
predicting PHLF in patients with resectable pCCA who require a major liver
resection.
Study design
A single-center, prospective proof-of-concept pilot study at Erasmus MC,
including a total of 40 patients that can be used for analysis. The expected
inclusion period is 3-4 years. All patients will preoperatively undergo CT
volumetric assessment and 99mTc-mebrofenin hepatobiliary scintigraphy (HBS)
(both standard of care) and Primovist enhanced MRI. In case of PVE, these
assessments will be performed before and after PVE.
Intervention
Primovist enhanced MRI.
Study burden and risks
The most common adverse events following Primovist enhanced MRI are transient
and of mild to moderate intensity. They include nausea and headache (1.1%),
feeling hot (0.8%), back pain (0.6%) and dizziness (0.5%).
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Suspected resectable pCCA (as determined by the multidisciplinary
hepatobiliary team, with or without histopathological confirmation), requiring
an (extended) hemihepatectomy.
- Age > 18 years.
- Total bilirubin below 50 micromol/L before MRI-Primovist.
Exclusion criteria
- Patients who are planned for extrahepatic bile duct resection only.
Patients with the following criteria are excluded to undergo Primovist enhanced
MRI:
- Contra-indication for MRI or gadoxetate disodium.
- Patients with known chronic liver disease based on liver function
measurements, imaging findings (fibroscan, elastography, or CT/MRI based signs
of cirrhosis and portal hypertension), and proven underlying hepatitis B/C or
chronic alcohol abusus.
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 | NL79047.078.22 |