Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000567527
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
2/06/2015
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
In colorectal metastases patients who require liver resection, does a surgeon having knowledge of liver fat measurements influence surgical planning decisions that result in improved patient outcomes.
Scientific title
In colorectal metastases patients who require liver resection, does a surgeon having knowledge of a quantitative measurement of liver fat influence surgical planning decisions that result in improved patient outcomes in comparison to patients where the surgeon had no knowledge of a quantitative measurement of liver fat.
Secondary ID [1] 286230 0
Nil
Universal Trial Number (UTN)
NIL
Trial acronym
LSFACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resection of colorectal liver metastases 294276 0
Condition category
Condition code
Surgery 294597 294597 0 0
Surgical techniques
Cancer 294598 294598 0 0
Liver
Cancer 295394 295394 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm – the surgeon will have knowledge of a quantitative measure of liver fat from MRI (HepaFat-Scan)
Intervention code [1] 291248 0
Treatment: Other
Comparator / control treatment
Active control - Standard treatment (surgeon has no knowledge of quantitative liver fat measurement)
Control group
Active

Outcomes
Primary outcome [1] 294369 0
Primary Outcome 1: all cause mortality as assessed by data linkage to medical records
Timepoint [1] 294369 0
Timepoint: within 3 months post surgery
Primary outcome [2] 294370 0
Primary Outcome 2: postoperative complications as assessed by data linkage to medical records (e.g. ascites, urine infection, bilioma, renal failure)
Timepoint [2] 294370 0
Timepoint: at baseline and 6 months post surgery
Primary outcome [3] 294371 0
Primary Outcome 3: deviations from standard surgical treatment as assessed by qualitative questionnaire designed specifically for this study
Timepoint [3] 294371 0
Timepoint: baseline
Secondary outcome [1] 313118 0
Secondary Outcome 1: all cause mortality as assessed by data linkage to medical records
Timepoint [1] 313118 0
Timepoint: at 6 months post surgery
Secondary outcome [2] 313119 0
Secondary Outcome 2: hospital stay as assessed by data linkage to medical records
Timepoint [2] 313119 0
Timepoint: post-surgery
Secondary outcome [3] 313120 0
Secondary Outcome 3: intraoperative blood loss as assessed by data linkage to medical records
Timepoint [3] 313120 0
Timepoint: one day post-surgery
Secondary outcome [4] 313121 0
Secondary Outcome 4: level of histopathologic steatosis as assessed by a visual inspection of a liver biopsy specimen by a pathologist
Timepoint [4] 313121 0
Timepoint: within 3 months post-surgery
Secondary outcome [5] 313122 0
Secondary Outcome 5: histopathologic steatosis (percentage area of fat occupying the slide) as assessed by computer assisted morphometric image analysis of a Masson trichrome stained liver biopsy section
Timepoint [5] 313122 0
Timepoint: within 3 months post-surgery
Secondary outcome [6] 313123 0
Secondary Outcome 6: liver functional status as assessed by standard liver biochemical assays
Timepoint [6] 313123 0
Timepoint: baseline and daily during hospital stay

Eligibility
Key inclusion criteria
colorectal liver metastases requiring liver resection, abdominal MRI with HepaFat-Scan (acquired after enrollment)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
contraindications for MRI

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/07/2015
Actual
3/09/2015
Date of last participant enrolment
Anticipated
Actual
27/03/2018
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
200
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 7204 0
Joondalup Health Campus - Joondalup
Recruitment hospital [2] 7205 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 7206 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 14968 0
6027 - Joondalup
Recruitment postcode(s) [2] 14969 0
6150 - Murdoch
Recruitment postcode(s) [3] 14970 0
2145 - Westmead
Recruitment outside Australia
Country [1] 8547 0
New Zealand
State/province [1] 8547 0
Auckland

Funding & Sponsors
Funding source category [1] 290792 0
Commercial sector/Industry
Name [1] 290792 0
Resonance Health Ltd
Country [1] 290792 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Resonance Health Ltd
Address
141 Burswood Road, Burswood, WA 6100
Country
Australia
Secondary sponsor category [1] 289474 0
University
Name [1] 289474 0
University of Western Australia
Address [1] 289474 0
35 Stirling Highway, Crawley, WA, 6009
Country [1] 289474 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292421 0
Joondalup Health Campus Human Research Ethics Committee
Ethics committee address [1] 292421 0
Ethics committee country [1] 292421 0
Australia
Date submitted for ethics approval [1] 292421 0
29/01/2015
Approval date [1] 292421 0
13/03/2015
Ethics approval number [1] 292421 0
1502
Ethics committee name [2] 294202 0
South Metropolitan Health Service
Ethics committee address [2] 294202 0
Ethics committee country [2] 294202 0
Australia
Date submitted for ethics approval [2] 294202 0
03/11/2015
Approval date [2] 294202 0
14/12/2015
Ethics approval number [2] 294202 0
15-199
Ethics committee name [3] 296601 0
Westmead Human Ethics Research Committee
Ethics committee address [3] 296601 0
Westmead Hospital, Hawkesbury & Darcy Roads, Westmead NSW 2145
Ethics committee country [3] 296601 0
Australia
Date submitted for ethics approval [3] 296601 0
30/04/2016
Approval date [3] 296601 0
19/08/2016
Ethics approval number [3] 296601 0
4743

Summary
Brief summary
The primary purpose of this study is to determine whether an accurate liver fat measurement, when reviewed by a surgeon, leads to changes in surgical approaches and hospital care that result in improved outcomes for colorectal metastases patients who require liver resection.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have colorectal liver metastases requiring liver resection.

Study details
All patients enrolled in this safety and tolerability study will have a liver resection and will be assigned by chance to surgery with the surgeon having knowledge of accurate fat liver measurements or to surgery where the surgeon is not aware of the liver fat content prior to starting the surgery. Patient outcomes will then be assessed through medical records. It is hoped that this study will aid in developing strategies that could lead to better survival and health outcomes for colorectal metastases patients after liver resection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55190 0
Prof Paul Moroz
Address 55190 0
Suite 24, Specialist Medical Centre, Joondalup Health Campus, Shenton Avenue, JOONDALUP WA 6027
Country 55190 0
Australia
Phone 55190 0
+61 8 94009690
Fax 55190 0
Email 55190 0
[email protected]
Contact person for public queries
Name 55191 0
Dr Michael House
Address 55191 0
Resonance Health Ltd, 141 Burswood Road, Burswood, WA 6100
Country 55191 0
Australia
Phone 55191 0
+61 8 9286 5300
Fax 55191 0
Email 55191 0
[email protected]
Contact person for scientific queries
Name 55192 0
Dr Michael House
Address 55192 0
Resonance Health Ltd, 141 Burswood Road, Burswood, WA 6100
Country 55192 0
Australia
Phone 55192 0
+61 8 9286 5300
Fax 55192 0
Email 55192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Sponsor has not completed assessment of all trial data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.