Condition category
Cancer
Date applied
28/04/2016
Date assigned
01/07/2016
Last edited
01/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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) daren.subar@elht.nhs.uk
2. Ms Linda Gregson (public) linda.gregson@elht.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Daren Subar

ORCID ID

Contact details

Department of Hepatpancreatbiliary Surgery
Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
01254 263555
daren.subar@elht.nhs.uk

Type

Public

Additional contact

Ms Linda Gregson

ORCID ID

Contact details

Research and Development Department
Royal Blackburn Hospital
Haslingden Road
Balckburn
BB2 3HH
United Kingdom
01254 263555
linda.gregson@elht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

LiverPRIMEii

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

Not provided at time of registration

Study design

Observational cohort study.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

1. Hepatic steatosis/intra-heaptic fat
2. Colorectal liver metastases
3. Neoadjuvant chemotherapy

Intervention

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 magenetic 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

Phase

Drug names

Primary outcome measures

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

01/10/2015

Overall trial end date

08/08/2017

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

30

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

01/06/2016

Recruitment end date

01/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

East Lancashire Hospitals NHS Trust
Royal Blackburn Hospital Haslingden Road
Blackburn
BB2 3HH
United Kingdom

Sponsor information

Organisation

East Lancashire Hospitals NHS Trust

Sponsor details

Royal Blackburn Hospital
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
01254 263555
linda.gregson@elht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

www.elht.nhs.uk

Funders

Funder type

Charity

Funder name

Rosemere Cancer Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes