NCT04705194: HEPARIM

Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging

Status unknown Last updated 22 January 2021

What this trial tests

trial testing Hepatectomy in Hepatectomy in 134 participants. Status unknown.

Timeline

8 July 2019

Primary endpoint
1 March 2022

1 June 2022

Quick facts

Lead sponsor	University of Leeds
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	134
Start date	8 July 2019
Primary completion	1 March 2022
Estimated completion	1 June 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Hepatectomy
• PVE or ALPPS

Conditions studied

• Hepatectomy — all drugs for Hepatectomy →
• Liver Failure — all drugs for Liver Failure →
• Liver Cancer — all drugs for Liver Cancer →
• Liver Metastases — all drugs for Liver Metastases →

Sponsor

University of Leeds

Who can join

Adults 19 to 79, any sex, with Hepatectomy or Liver Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hepatectomy risk assessment with functional magnetic resonance imaging (HEPARIM).
   Elsharif M, Roche M, Wilson D, Basak S, et al · · 2021 · cited 4× · PMID 34688256 · DOI 10.1186/s12885-021-08830-4