Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging

Summary

Liver resection remains the only curative option for primary or metastatic liver cancer, but a more accurate prediction of post-hepatectomy liver failure (PHLF) is needed to further reduce morbidity and mortality and to extend the indication to a wider patient population. Magnetic resonance Imaging (MRI) is a promising new source of liver function tests as it can provide segmental function alongside measurements of perfusion, tissue structure and standard morphological assessment.

The primary aim of HEPARIM is to determine if quantitative MRI biomarkers of liver function and perfusion can improve predictions of post-hepatectomy liver function, as measured by an indocyanine green (ICG) liver function test. Secondary aims is to validate the MRI measurements of liver function against ICG.

HEPARIM is an observational cohort study recruiting patients referred locally for a one- or two-stage liver resection of 2 segments or more. Before surgery, all participants will undergo an ICG liver function test and a Dynamic Gadoxetate-enhanced (DGE) MRI scan of the liver. The ICG test will be repeated at one day after surgery. The Gadoxetate Clearance (GC) of the future liver remnant (FLR-GC) will be determined from the DGE-MRI data and correlated to the post-operative ICG R15 as primary outcome measure. Preoperative ICG R15 will be correlated against GC of the whole liver (WL-GC) to address the secondary objective. In patients that undergo a staged hepatectomy, an additional MRI and ICG test will be performed before the first stage to assess its effect on volumetric and functional growth of the FLR.

Additional pre- and postoperative data will be collected from medical records including demographics and medical histories, biochemistry, pathology and radiology reports, and any long-term outcome data collected in the 90-day follow-up visit. These data will be used in a multi-variate analysis to determine which preoperative biomarkers are most predictive of immediate and long-term outcomes, to identify the added value of functional MRI over routine clinical markers, and to derive a multi-variate prediction model that can be validated in future studies.

Conditions

• Hepatectomy
• Liver Failure
• Liver Cancer
• Liver Metastases

Interventions

PROCEDURE

Hepatectomy

Resection of one or more liver segments as treatment for primary or metastatic liver cancer

PROCEDURE

PVE or ALPPS

Embolization of the portal vein feeding the diseased liver segments or surgical liver partition and portal vein ligation of the diseased liver segments in order to induce growth of the future liver remnant ahead of the resection.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• University of Sheffield

  collaborator OTHER

• University of Leeds

  lead OTHER

Principal Investigators

• Steven Sourbron, PhD · University of Sheffield

Eligibility

Min Age

19 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-08

Primary Completion

2022-03-01

Completion

2022-06-01

Countries

• United Kingdom

Study Locations