ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

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

Liver Transplant

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

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]

Not applicable

Comparator / control treatment

Consultant anaesthetists who are not members of the liver transplant ream

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

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]

1 year

Secondary outcome [2]

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]

1 year

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Liver Transplant Unit
Austin Health
145 Studley Road
Heidleberg
Victoria
3084

Country [1]

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]

None

Name [1]

None

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee.

Ethics committee address [1]

Austin Health
145 Studley Road
Heidleberg
Victoria
3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2018

Approval date [1]

19/12/2018

Ethics approval number [1]

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

Dr Ruth Shaylor

Address

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

Australia

Phone

+972535676112

Fax

ruth@shaylor.co.uk

Contact person for public queries

Name

Ruth Shaylor

Address

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

Australia

Phone

+972535676112

Fax

ruth@shaylor.co.uk

Contact person for scientific queries

Name

Ruth Shaylor

Address

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

Australia

Phone

+972535676112

Fax

ruth@shaylor.co.uk

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.

Trial Review

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