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The CLiFF Study:

Change in Liver Function and Fat in Pre-operative Chemotherapy for Colorectal Liver Metastases

The CLiFF Study is running at the Christie NHS Foundation Trust in Manchester, UK, utilising two novel technologies to assess changes in the liver related to pre-operative chemotherapy for colorectal liver metastases:

  1. Humedics LiMAx Test to assess liver function
  2. Advanced MR imaging (including the Perspectum Diagnostics LiverMultiScan) to assess changes in liver fat

Aim: 

To prospectively evaluate changes in liver function and liver fat resulting from pre-operative chemotherapy for colorectal liver metastases

Background:

Chemotherapy is associated with liver injury and increased liver fat deposition, which have been linked to adverse liver resection outcomes

Methods:

This is a prospective observational longitudinal study of 35 patients. Liver function & fat are measured before, during & after chemotherapy for CLM, using cutting edge techniques and novel technology. These primary outcomes will be correlated with the following secondary outcome measures: routine liver enzymes, BMI, CT-derived anthropometric measurements (SAT, VAT and muscle mass), digital histological quantification of intra-hepatic fat, histological NAS-CRN routine steatosis score, post-operative outcomes (morbidity & mortality)

Liver Function Measurement – The LiMAx test (Liver Maximum Capacity)

(This is the first use of the LiMAx test in the UK)

This novel breath test provides real-time highly sensitive information on individual liver function. It directly determines the metabolism of 13C-methacetin to 13CO2 by a hepatocyte-specific enzyme system. The LiMAx test is currently undergoing a National Institute of Clinical Excellence technology assessment.

Liver Fat Measurement – Advanced MR Imaging

Two cutting-edge techniques – MR spectroscopy and modified Dixon technique, developed as part of the Manchester Cancer Research Programme, are performed at the Wolfson Molecular Imaging Centre. In addition, a further analysis of liver fat is provided by the Perspectum Diagnostics LiverMultiScan.

Patient Flow Through Study:

Ethics and Registration

The CLiFF Study has received ethical approval from an NHS Research Ethics Committee and is registered online HERE with ClinicalTrials.gov.

Funding

The CLiFF Study is grateful to the Royal College of Surgeons of England for awarding Kat Parmar with a One-Year Surgical Research Fellowship towards completing this research.

The study is also grateful to have received support from the following sources:

 

Timeline:

Recruitment to this study closed early in April 2020 due to the impact of COVID-19 – the project is currently in the data analysis stage

 

Study Team:

The CLiFF Study is being carried out as part of a University of Manchester PhD Thesis (K Parmar) with the following supervisory team: