Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000690156
Ethics application status
Approved
Date submitted
5/05/2019
Date registered
8/05/2019
Date last updated
8/05/2019
Date data sharing statement initially provided
8/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of Smart Phone Technology in Predicting Liver Viability Pre Biopsy
Scientific title
Will Tech's Triumph? Yes/No: Visual Inspection Pre-Biopsy
The ability of different health care professionals to assess the viability of a potential donor liver from photographs taken of the organ in situ
Secondary ID [1] 298157 0
None
Universal Trial Number (UTN)
U1111-1232-8500
Trial acronym
WiTTY VIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Organ Donation 312705 0
Liver Transplant 312706 0
Condition category
Condition code
Surgery 311206 311206 0 0
Other surgery
Oral and Gastrointestinal 311227 311227 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No of Participants: 25: 5 Liver transplant surgeons > 1 year experience; 5 Theatre technicians > 1 year experience; 5 Transplant coordinators > 1 year experience; 5 Consultant anaesthetists > 1 year experience; 5 Liver Pathologists >1 year experience.

Time Scale: 1 year

Method: The pictures of 25 organ procurements will be taken from existing records and de-identified (50 pictures total). Each participant will be sent an invitation to their Austin Health email to participate in this project with a link to a REDCaps survey.

Consent will be implied by filling out the survey. Anyone not wishing to take part will not be required to do so.

The survey will contain the following demographic questions: Occupation, Number of years in current role. There will then be an image showing pre and post perfusion pictures of a donor liver and participants will be asked to assess them for organ viability, organ age (to nearest 10 years), percentage fat (nearest 5%) and fibrosis score. In order to maintain interest, there will also be two sham photos (chopped liver, foie grass). The survey will take approximately 10 minutes to complete and can only be filled out by each participant once.

We will ask participants to fill out the survey using their smartphones as this will mimic the conditions they are likely to see pre procurement liver photos in the clinical setting

The survey results will be exported into an Excel spread sheet prior to data analysis. Answers for each group would be compared with actual donor age, organ viability and the laboratory result for percentage fat.

Data Analysis: The results for each group will be combined and receiver operating curves constructed.
Intervention code [1] 314380 0
Not applicable
Comparator / control treatment
Consultant anaesthetists who are not members of the liver transplant ream
Control group
Active

Outcomes
Primary outcome [1] 319966 0
Ability to predict if a donor liver is suitable for transplant using photos only. Participants will be shown pre and postperfusion phots of donor livers via a RedCaps survey some of which are suitable for transplant and some of which are not. They will be asked as part of the survey whether they think the organ in the picture is suitable for transplant. The results for each care provider subgroup will be collated and a user response curve created
Timepoint [1] 319966 0
1 year - The survey its self should only take 10 minutes however the whole project (making the survey, collating and analysing results) will take a year
Secondary outcome [1] 369997 0
Abitily to predict fat content of a donor liver by looking at a photo of it. The results for each care provider subgroup will be collated and a user response curve created
Timepoint [1] 369997 0
1 year
Secondary outcome [2] 369998 0
Ability to predict fibrosis score of a liver by looking at a photo of it. The results for each care provider subgroup will be collated and a user response curve created
Timepoint [2] 369998 0
1 year
Secondary outcome [3] 369999 0
ability to predict the age of a donor lover by looking at a photo of it. The results for each care provider subgroup will be collated and a user response curve created
Timepoint [3] 369999 0
1 year

Eligibility
Key inclusion criteria
Members of the liver team at Austin Health including:
- Consultant Surgeons
- Transplant Co-ordinators
- Transplant technicians
- Liver pathologists

Consultant Anesthetists at Austin Health who are not members of the liver team.

All participants must have a minimum of 1-year experience in their current role
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anaesthetists who are currently or have in the past been part of the liver team
Refusal to participate

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The results for each group will be pooled to make user response curves

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2019
Actual
Date of last participant enrolment
Anticipated
28/09/2019
Actual
Date of last data collection
Anticipated
28/05/2020
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13688 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26379 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 302684 0
Hospital
Name [1] 302684 0
Austin Health
Country [1] 302684 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Department of Anaesthesia
Austin Health
145 Studley Road
Heidleberg
Victoria
3084
Country
Australia
Secondary sponsor category [1] 302616 0
None
Name [1] 302616 0
None
Address [1] 302616 0
none
Country [1] 302616 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303302 0
Austin Health Human Research Ethics Committee.
Ethics committee address [1] 303302 0
Austin Health
145 Studley Road
Heidleberg
Victoria
3084
Ethics committee country [1] 303302 0
Australia
Date submitted for ethics approval [1] 303302 0
07/12/2018
Approval date [1] 303302 0
19/12/2018
Ethics approval number [1] 303302 0
QI 31291

Summary
Brief summary
Currently transplant during organ procurement specially trained theatre technicians take photos of the potential donor liver prior to aortic cross clamp and following reperfusion. These pictures are then sent to the transplant surgeon, transplant coordinator, liver pathologist via secure communication and stored on the liver database. In addition a biopsy is sent to the lab to confirm viability. On the basis of these pictures the surgeon either decides to go ahead with surgery or wait for the biopsy. An operating theatre is placed on hold from the time the team leave for organ retrieval until the biopsy results come back at which point they either proceed with the transplant or cancel it. This process can take several hours during which time each person who has seen the photo claims to be as accurate as the eventual laboratory result in predicting organ viability, organ age and organ fat content. We would like to create user response curves to see if there is a correlation between health care provider groups and their ability to predict organ viability in liver transplant
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93198 0
Dr Ruth Shaylor
Address 93198 0
Department of Anaesthesia
Austin Health
145 Studley Road
Heidleberg
Victoria
3048

NB - I am an honorary researcher as Austin Health but live in Israel hence the different area code
Country 93198 0
Australia
Phone 93198 0
+972535676112
Fax 93198 0
Email 93198 0
[email protected]
Contact person for public queries
Name 93199 0
Dr Ruth Shaylor
Address 93199 0
Department of Anaesthesia
Austin Health
145 Studley Road
Heidleberg
Victoria
3048

NB - I am an honorary researcher as Austin Health but live in Israel hence the different area code
Country 93199 0
Australia
Phone 93199 0
+972535676112
Fax 93199 0
Email 93199 0
[email protected]
Contact person for scientific queries
Name 93200 0
Dr Ruth Shaylor
Address 93200 0
Department of Anaesthesia
Austin Health
145 Studley Road
Heidleberg
Victoria
3048

NB - I am an honorary researcher as Austin Health but live in Israel hence the different area code
Country 93200 0
Australia
Phone 93200 0
+972535676112
Fax 93200 0
Email 93200 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?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
upon email request to the principal investigator following publication. there will be no end date
Available to whom?
researchers in other liver centers who request
Available for what types of analyses?
any requested
How or where can data be obtained?
email request to the principal investigator and secured database


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.