Clinical trial · Observational
Hepatectomy Risk Assessment With Functional Magnetic Resonance Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatectomy | — | UNRESOLVED | — |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Failure | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepatectomy | Procedure | — | UNRESOLVED |
| PVE or ALPPS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- One stage resection
- description
- Patients that are selected for a single hepatectomy of 2 segments or more.
- interventionNames
- Procedure: Hepatectomy
- label
- Two stage resection
- description
- Patients that are selected for a two-stage resection, where the first stage consists of either PVE or ALPPS and the second stage is a hepatectomy of 2 or more segments.
- interventionNames
- Procedure: Hepatectomy
- Procedure: PVE or ALPPS
Primary outcomes (1)
- measure
- Correlation coefficient between preoperative FLR-GC and post-operative ICG R15
- timeFrame
- End of 2 year recruitment
- description
- Correlation between preoperative estimates of liver function using gadoxetate clearance of the FLR (FLR-GC) derived from MRI data and post-operative measurement of liver function using ICG clearance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: Adults over 18 years of age and under 80 years * Referred to the hepatobiliary surgical service at St James's Hospital * Diagnosed with any hepatic tumour * One of: i) Referred for liver resection (defined as two or more Couinaud segments) by multi-disciplinary team discussion at Saint James's Hospital (One stage arm) ii) OR Referred for PVE or ALPPS prior to likely major hepatectomy by multi-disciplinary team discussion at Saint James's Hospital (Two stage arm) Exclusion Criteria: * Unable to consent independently * Previous liver resection * Private patients * Concurrent malignancy unrelated to liver tumour * Chronic renal failure (estimated Glomerular Filtration Rate \< 30 mL/min) * Possible pregnancy * Other contraindications to DGE-MRI, including: i) Cochlear Implant ii) Aneurysm Clips iii) Neurological stimulator iv) Implanted cardiac devices v) Metal heart valve vi) History of metal foreign bodies in orbits vii) Other implanted metal device which prevents MRI viii) Known allergy to Gadolinium contrast ix) Claustrophobia x) Weight exceeding 250 kg xi) Maximal diameter exceeding 55cm * Other contraindications to ICG i) Known allergy to Indocyanine green ii) Known allergy to sodium iodine iii) Known reaction or allergy to iodine iv) Previous diagnosis of a thyroid problem v) Breastfeeding
References
Publications (1)
- DERIVEDElsharif M, Roche M, Wilson D, Basak S, Rowe I, Vijayanand D, Feltbower R, Treanor D, Roberts L, Guthrie A, Prasad R, Gilthorpe MS, Attia M, Sourbron S. Hepatectomy risk assessment with functional magnetic resonance imaging (HEPARIM). BMC Cancer. 2021 Oct 23;21(1):1139. doi: 10.1186/s12885-021-08830-4. PMID 34688256