bile duct cancer Biliary tract cancer
Conditions
Interventions
Primovist enhanced MRI.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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
| Measure | Time frame |
|---|---|
| • 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). | — |
Countries
Netherlands
Outcome results
None listed