HEPARIM
Research type
Research Study
Full title
Hepatectomy Risk Assessment with Functional Magnetic Resonance Imaging
IRAS ID
240787
Contact name
Steven Sourbron
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
12 years, 6 months, 1 days
Research summary
Major liver resection is an operation commonly performed for patients with cancer in the liver. Post-hepatectomy liver failure (PHLF) is a common cause of mortality and morbidity, and occurs when the patient is left with insufficient liver for their body size after surgery. There is no treatment available for PHLF beyond supportive interventions.
It is vital that surgeons are certain that patients will have sufficient liver remaining after their surgery to avoid PHLF. Unfortunately this is difficult to determine as the volume of liver required to sustain the patient depends on the health of the liver. Currently, techniques to predict post-operative function are not accurate, leaving diagnostic uncertainty. As a result, some patients who are eligible for surgery may be deemed ineligible, and some patients at high risk of PHLF will undergo surgery inappropriately.
Dynamic gadoxetate enhanced magnetic resonance imaging (DGE-MRI) allows improved estimation of post-operative liver function by combining data on the function of liver segments with anatomical imaging. The data can be acquired on widely available MRI scanners and requires only a small change to a patient's routine pre-operative imaging. The only comparable technique (Hepatobiliary Scintigraphy) is only available in limited numbers of specialist centres.
This observational cohort study will determine whether DGE-MRI can predict post-operative liver function reliably, by comparing predictions against post-operative measurements of liver function with a gold-standard technique based on Indocyanine Green (ICG) clearance.
Patients selected for major liver resection will be recruited and pre-operative MRI will be performed including DGE-MRI. ICG will be performed post-operatively and compared to pre-operative predictions of post-operative function. ICG will also be performed pre-operatively to allow a direct comparison with DGE-MRI as a secondary aim.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0139
Date of REC Opinion
18 Apr 2019
REC opinion
Further Information Favourable Opinion