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Trial registered on ANZCTR


Registration number
ACTRN12619000680167
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
7/05/2019
Date last updated
7/05/2019
Date data sharing statement initially provided
7/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Very low-energy diet before surgery in obese patients undergoing partial liver excision: a pilot randomised control trial (Very SuPPLE Trial)
Scientific title
Very low-energy diet before surgery in obese patients undergoing partial liver excision: a pilot randomised control trial (Very SuPPLE Trial)
Secondary ID [1] 298061 0
none
Universal Trial Number (UTN)
Trial acronym
Very SuPPLE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Cancer 312557 0
Obesity 312655 0
Condition category
Condition code
Cancer 311076 311076 0 0
Liver
Diet and Nutrition 311150 311150 0 0
Obesity
Surgery 311151 311151 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be provided Optifast by their consulting physician and given a food diary. The two weeks’ worth of Optifast (Optifast milkshakes), which consists of three replacement meals (150 kcal per meal replacement) per day, will be given to the patient and they will be advised of the daily water requirements and other low calorie they should include to provide a total daily energy intake of approximately 800 kcal (3.3MJ).
Trial participants have a water requirement of at least 2 litres of fluid including the VLED every day. This amounts to 8 cups of water, milk-free tea or coffee, low calorie soft drink, low calorie cordial every day. The only additional foods permitted include low calorie jelly, strained broth and certain vegetables. A teaspoon of vegetable or olive oil to the vegetable intake each day will be required to assist with gall bladder contraction in the absence of additional fat in the diet. The required water and the optional additional broth / vegetables will be provided by the participants.
Participants will also complete a baseline QOL questionnaire
Intervention code [1] 314320 0
Treatment: Other
Comparator / control treatment
This group will receive routine preoperative care as part of their cancer treatment from diagnosis to liver surgery. While it is common to encourage patients with high BMI to lose weight, no specific encouragement of a VLCD program will be discussed. These participants will also be provided a food diary and encouraged to complete it truthfully. Participants will also complete a baseline QOL questionnaire
Control group
Active

Outcomes
Primary outcome [1] 319889 0
Feasibility:
Composite primary outcome, conisisting of feasibility of patients undergoing a two-week trial of VLCD will be assessed by the recruitment, retention and adherence of the participants. The recruitment will be calculated by the number of eligible participants recruited. Retention will be assessed by the proportion of patients in the intervention arm able to complete the intervention and adherence will be calculated by the percentage of the two-week VLCD regimen that was able to be completed from food record diaries.
Timepoint [1] 319889 0
at end of study period
Secondary outcome [1] 369788 0
Assessment of change in liver size using ultrasound-guided elastography.
Timepoint [1] 369788 0
baseline and 2-weeks post intervention
Secondary outcome [2] 369790 0
To assess is the use of VLED/VLCD impacts patient's Quality of life using the SF-36
Timepoint [2] 369790 0
baseline, 2 weeks post intervention & 3 months post surgery
Secondary outcome [3] 369794 0
To assess if the use of VLCD/VLED makes surgery technically easier. This will be assessed using the NASA TLX
Timepoint [3] 369794 0
immediately post-surgery
Secondary outcome [4] 369815 0
Assessment of the cost-effectiveness of trial. Measured using the AQoL-8D and Labour Force survey
Timepoint [4] 369815 0
at time of discharge
Secondary outcome [5] 369897 0
Assessment of change in liver steatosis with ultrasound-guided elastography.
Timepoint [5] 369897 0
At baseline and at surgery
Secondary outcome [6] 369898 0
Number of blood transfusion from medical records.
Timepoint [6] 369898 0
within 48hrs of surgery
Secondary outcome [7] 369899 0
post-operative liver failure (defined as the impaired ability of the liver to maintain it synthetic, excretory and detoxifying function characterised by increased international normalized ratio and concomitant hyperbilirubinemia). from medical records
Timepoint [7] 369899 0
post-surgery to discharge
Secondary outcome [8] 369900 0
bile leakage (defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis). from medical records
Timepoint [8] 369900 0
post-surgery to discharge
Secondary outcome [9] 369901 0
reoperation, from medical records
Timepoint [9] 369901 0
30 days post surgery
Secondary outcome [10] 369902 0
death as noted in medical records
Timepoint [10] 369902 0
30 days post surgery
Secondary outcome [11] 369903 0
presence of clear margins in the histopathological specimen , as noted in medical records
Timepoint [11] 369903 0
post-surgery

Eligibility
Key inclusion criteria
(i) Body Mass Index (BMI) >30 (obese); or a BMI >27 and a waist circumference in obese range (Caucasian – female >88cm, male >102cm; Asian/Aboriginal – female >30cm, male >90cm)
(ii) Undergoing liver resection surgery
(iii) Presenting to an Upper Gastrointestinal surgeon 2 week prior to surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Clinically malnourished
(ii) Pregnant or breastfeeding
(iii) Have a comorbidity which prohibits restrictive dieting (in consultation with an endocrinologist), or a contra-indication to VLED (eg porphyria, recent myocardial infarction, unstable angina)
(iv) Have a contraindication to (ICG) (iodine hypersensitivity, dialysis, renal failure)
(v) Have cognitive impairment such as they cannot give consent, or
(vi) Have inadequate English language skills to understand the intervention/ study.

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)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out on a 1:1 basis by a computer-based random sequence generator in the REDCap System. Variable sized blocks will be used to ensure approximately equal numbers in the two trial arms. Participants will be stratified on if they chemotherapy or not prior to intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proportion of patients who consent to the study and reasons for non-consent will be summarised. Characteristics of patients randomised to each group will be compared. The number of and percentage of the intervention group who commenced and completed the program will be calculated. Those who did not complete the full program, the reasons for not completing treatment preoperatively will be analysed. Secondary outcomes will be compared between control and intervention groups. ICG clearance and US elastography will be compared before and after the VLED. Immediate peri-operative ICG clearance and US elastography results will be compared to histopathological results of peri-tumoral liver tissue (i.e. background liver tissue) to assess for any correlation. The six clinical outcomes outlined above will be compared between intervention and control groups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13672 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 26354 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 302594 0
University
Name [1] 302594 0
Central Clinical School; University of Sydney
Country [1] 302594 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Executive Offices
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 302545 0
None
Name [1] 302545 0
Address [1] 302545 0
Country [1] 302545 0
Other collaborator category [1] 280657 0
Other
Name [1] 280657 0
Surgical Outcomes Research Centre
Address [1] 280657 0
Level 9, Building 89
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050

Mailing address:
PO Box M157
Missenden Road
Camperdown, NSW 2050
Country [1] 280657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303229 0
Sydney Local Health District (RPAh Zone)
Ethics committee address [1] 303229 0
Ethics committee country [1] 303229 0
Australia
Date submitted for ethics approval [1] 303229 0
Approval date [1] 303229 0
21/02/2019
Ethics approval number [1] 303229 0
X18-0233 & HREC/18/RPAH/314

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92930 0
Dr David Yeo
Address 92930 0
mail to: Suite 1 54-60 Briggs Street Camperdown NSW 2050

Royal Prince Alfred Hospital
Missenden Road, Camperdown NSW 2050
Country 92930 0
Australia
Phone 92930 0
+61 28937 2213
Fax 92930 0
Email 92930 0
[email protected]
Contact person for public queries
Name 92931 0
David Yeo
Address 92931 0
mail to: Suite 1 54-60 Briggs Street Camperdown NSW 2050

Royal Prince Alfred Hospital
Missenden Road, Camperdown NSW 2050
Country 92931 0
Australia
Phone 92931 0
+61 28937 2213
Fax 92931 0
Email 92931 0
[email protected]
Contact person for scientific queries
Name 92932 0
David Yeo
Address 92932 0
mail to: Suite 1 54-60 Briggs Street Camperdown NSW 2050

Royal Prince Alfred Hospital
Missenden Road, Camperdown NSW 2050
Country 92932 0
Australia
Phone 92932 0
+61 28937 2213
Fax 92932 0
Email 92932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal on a case-by-case basis at the discretion of Primary Sponsor and Chief investigators
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access will be subject to approvals by Principal Investigator and approved proposals will require a signed data access agreement.


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.