Preoperative functional liver assesement with primovist enhanced MRI for patients with suspected resectable perihilar cholangiocarcinoma: a proof-of-concept pilot study

• Conditions: bile duct cancer; Biliary tract cancer; 10004606

• Registration Number: NL-OMON52335
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To assess whether MRI Primovist could replace 99mTc-mebrefenin HBS as a<br /><br>preoperative functional liver assessment in addition to CT-volumetry in<br /><br>predicting PHLF in patients with resectable pCCA who require a major liver<br /><br>resection. </p><br>