Condition category
Digestive System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background & Aims
The presence of liver fat with or without inflammation is an independent risk factor for disease and death mortality and morbidity) following the removal (resection) of colorectal liver metastases (bowel cancer tumours that have spread to the liver). High levels of fat in the liver can be linked with obesity (being very overweight) and insulin resistance or it may be caused through neoadjuvant chemotherapy (chemotherapy before surgery). Dietary programmes ( interventions) have been proposed for patients that are not receiving chemotherapy and have an excess of liver fat, but it is not known if similar interventions would be benefit patients with chemotherapy induced fatty changes (fatty changes caused by chemotherapy) . This is because it is not known to what extent this naturally resolves after chemotherapy has been completed in the conventional 4-6 week period between chemotherapy and surgery (washout period). This study looks to investigate changes in liver fat levels within this washout period after chemotherapy.

Who can participate?
Anybody over the age of 18 years old who has or will receive chemotherapy before surgery to remove colorectal liver metastases.

What does the study involve?
Each participant is asked to attend Royal Blackburn Hospital on 2 occasions. The first visit takes place around the time that the participant completes their course of chemotherapy. During this first visit a blood sample is taken to assess liver function, circulating blood fat levels and sugar level control. An indocyanine green clearance test is performed which is a newer more sensitive test of liver function than older blood tests. The participant also has a short chemical shift magnetic resonance scan. On the second visit, 4-5 weeks later, these investigations are performed again.

What are the possible benefits?
There are no perceived benefits to participants. Travel expenses will be reimbursed to alleviate any financial burden.

When is the study starting?
October 2015 to August 2017

Who is funding the study?
Rosemere Cancer Foundation (UK)

Where is the study running?
East Lancashire Hospitals NHS Trust, Blackburn (UK)

Who is the main contact?
1. Mr Daren Subar (scientific)
2. Ms Linda Gregson (public)

Trial website

Contact information



Primary contact

Mr Daren Subar


Contact details

Department of Hepatpancreatbiliary Surgery
Royal Blackburn Hospital
Haslingden Road
United Kingdom
01254 263555



Additional contact

Ms Linda Gregson


Contact details

Research and Development Department
Royal Blackburn Hospital
Haslingden Road
United Kingdom
01254 263555

Additional identifiers

EudraCT number number

Protocol/serial number

Study Protocol v2.0

Study information

Scientific title

An assessment of the natural progression of iatrogenic changes in intra-hepatic fat levels following cessation of neoadjuvant chemotherapy for colorectal liver metastases



Study hypothesis

Iatrogenic increases in intra-hepatic fat levels remain static follwing cessation of neoadjuvant chemotherapy before hepatic resection of colorectal liver metastases.

Ethics approval

North West – Preston Research Ethics Committee, 11/05/2016, ref: 16/NW/0416

Study design

Observational cohort study

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet


Hepatic steatosis/intra-hepatic fat in patients with colorectal liver metastases who are undergoing neoadjuvant chemotherapy


30 patients in receipt of neoadjuvant chemotherapy for metachronous colorectal liver metastases will be asked to attend Royal Blackburn Hospital on 2 occassions.

During first visit, at cessation of neoadjuvant chemotherapy, participants will undergo chemical shift magnetic resonance scan, indocyanine green clearance test, serum liver function tests, serum markers of glycaemic control and lipid profile.

These investigations will be repeated 4-5 weeks later in the immediate pre-operative period.

Statistical analysis will be carried out to test for significant differences in quantification of intra-hepatic fat.

Intervention type



Drug names

Primary outcome measure

Intrahepatic fat fraction as measured by 2 Chemical Shift Magnetic Resonance scans greater than 24 hours apart.

Secondary outcome measures

1. Indocyanine Green Plasma Disappearance Rate and Retention at 15 minutes, measured using a PULSiON Indocyanine Green Clearance Testing Device. This will be measured at visit 1 (Week 0 - at cessation of chemotherapy) and 4 weeks later (pre-operatively)
2. BMI, Height, Weight and Hip to Waist ratio, measured at visit 1 (Week 0 - at cessation of chemotherapy) and 4 weeks later (pre-operatively)
3. Assessment of Liver function, Glycaemic control and Lipid profile, including Bilirubin, AST, ALT, ALP GGT, HbA1c, Random Glucose, Triglycerides and Cholesterol at visit 1 and 2

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients must be able to receive and understand verbal and written information regarding the study and give written, informed consent.
2. Patients in receipt of neoadjuvant chemotherapy for CRLM.
3. Persons over 18 years old

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Persons under 18 years of age.
2. Conditions in which the supine position and breath holds required for MR scanning are not possible.
3. Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs.
4. Persons with contraindications to MR imaging- presence of cardiac pacemaker/artificial heart valve/aneurysm clips/metallic fragments in eyes/cochlear implants
5. Pre-existing chronic liver pathology such as haemachromatosis, viral hepatitis or primary hepatic malignancy.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

East Lancashire Hospitals NHS Trust
Royal Blackburn Hospital Haslingden Road
United Kingdom

Sponsor information


East Lancashire Hospitals NHS Trust

Sponsor details

Royal Blackburn Hospital
Haslingden Road
United Kingdom
01254 263555

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Rosemere Cancer Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

We anticipate the results of this study to be published by peer­‐reviewed journals and presented at international surgical, anaesthetic and perioperative medicine conferences.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/03/2020: Internal review. 31/08/2017: Ethics approval information added.