ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000508673

Ethics application status

Approved

Date submitted

5/04/2023

Date registered

17/05/2023

Date last updated

25/10/2024

Date data sharing statement initially provided

17/05/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Can a new standard of radiology reporting help improve diagnosis of pancreatic cancer?

Scientific title

SCANPatient: Synoptic reporting of CT scans assessing cancer of the pancreas. A multi-centre batched stepped-wedge, comparative effectiveness randomised controlled trial

Secondary ID [1]

MRF2015163

Universal Trial Number (UTN)

Trial acronym

SCANPatient (Synoptic reporting of Computerised tomography scans Assessing caNcer of the pancreas)

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pancreatic cancer

Condition category

Condition code

Cancer

Pancreatic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Suspected pancreatic cancer patients listed for multidisciplinary meeting (MDM) discussion will have their abdominal CT scans assessed prior to the MDM by radiologist. The radiologist will use a structured (synoptic) reporting tool to describe in detail the anatomical nature of their disease and document this.
The synoptic report collects around 60 discrete fields of data that describe in detail the pancreatic cancer mass characteristics, blood vessel involvement and determines the extent of any disease spread (metastases). It includes an inherent diagnostic algorithm from the international consensus guidelines that helps define clearly resectable (CR), borderline resectable (BR) or locally advanced (LA) pancreatic ductal adenocarcinoma. The synoptic reporting template has been developed through close consultation with pancreatic surgeons and specialist radiologists, and it has been piloted in two hospitals in Melbourne and shown to increase the accuracy of reporting. This new RCT is to investigate whether the introduction of the structured synoptic report across Australian institutions involved in the management of pancreatic cancer provides greater accuracy of staging and diagnosis of the disease.

Radiologists will be provided individual login details to access and complete the reporting tool built on the REDCap platform. The median time needed to complete a synoptic report for a patient by a radiologist during the pilot of this synoptic report was 4 minutes, so it is assumed the time will be similar for this study. Radiologists will undergo a brief training program in the implementation of the synoptic template report. No additional skills or training is required to actually report these CT scans (which is within the usual scope of practice of the radiologists) – it simply requires the completion of the synoptic template report. The brief training will be provided by a project data manager and an experienced radiologist who had previously used the tool. The training session will be delivered online and it will take about 30 minutes to complete.
To monitor adherence to the synoptic reporting, the data manager in central project team will ensure data completeness and accuracy, quality assurance checks and audits (quality control), as well as providing ongoing training and support to participating radiologists.
This trial has a batched stepped wedge cluster-randomised study design. Hospitals will start the study in 3 batches; data collection in each batch starting up to 2 months after the start of the previous batch. In each batch, 2-3 hospitals will be randomised to the sequences of the stepped wedge design. All hospitals will continue to use their current radiology reporting processes for an initial period of at least six months. Within each batch, after each six-month period, a group of 2-3 hospitals will be randomised and commence using the new synoptic template report, until all hospitals are using the new report.
Note: The pilot study was NOT registered with the ANZCTR or any other trial registry.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

The comparator for this study is continued use of the baseline standard radiology reporting process at each of the participating sites (prior to randomisation to synoptic reporting).

Baseline standard radiology reporting varies, the level of detail and the style of the report being radiologist dependent. The report is dictated by radiologists reviewing scans and usually written as a narrative of varying lengths and complexity, finishing with a conclusion (this is the core work of a radiologist, i.e., reporting CT scans).

Control group

Active

Outcomes

Primary outcome [1]

Patient diagnosed with BR pancreatic ductal adenocarcinoma (PDAC) (yes/no). The primary objective of this trial is to determine the change in the proportion of patients diagnosed with BR PDAC before and after introduction of the synoptic report.
The definition of BR-PDAC is radiological derived from the international consensus document. No further tests or tools are required to assign a radiological allocation of BR-PDAC other than the index CT scan.

Timepoint [1]

Borderline resectability of each patient will be determined at the time of each patient’s assessment.
Cumulative data will be assessed at the conclusion of the study to determine the changes in the proportion of patients diagnosed with BR PDAC.

Secondary outcome [1]

Patient diagnosed with CR (yes/no). To determine the change in the proportion of patients with CR in a prospective cohort of patients with PC.
No further tests or tools are required to assign a radiological allocation of the specific type of PDAC other than the index CT scan.

Timepoint [1]

Resectability of each patient will be determined at the time of each patient’s assessment.
Cumulative data will be assessed at the conclusion of the study to determine the changes in the proportion of patients diagnosed with the specific type of PDAC.

Secondary outcome [2]

Patient diagnosed with BR (yes/no). To determine the change in the proportion of patients with BR in a prospective cohort of patients with PC.
No further tests or tools are required to assign a radiological allocation of the specific type of PDAC other than the index CT scan.

Timepoint [2]

Secondary outcome [3]

Patient diagnosed with LA PDAC (yes/no). To determine the change in the proportion of patients with LA in a prospective cohort of patients with PC.
No further tests or tools are required to assign a radiological allocation of the specific type of PDAC other than the index CT scan.

Timepoint [3]

Secondary outcome [4]

Patients planned to receive neoadjuvant chemotherapy (yes/no). To determine the change in the proportion of patients with CR PDAC planned to have neoadjuvant chemotherapy.
The multidisciplinary team (MDT) Discussion outcome document will clarify what the treatment plan is for each individual patient. If this plan documents ‘plan to receive neoadjuvant chemotherapy’ then that is a ‘yes’ to ‘plan to receive neoadjuvant therapy’. The proportion of patients who have this plan before and after the synoptic report is introduced for CR will be therefore calculated. In short, the primary source document (MDT discussion outcome) will provide the answer.

Timepoint [4]

At the time of the MDT

Secondary outcome [5]

Patients planned to receive neoadjuvant chemotherapy (yes/no). To determine the change in the proportion of patients with BR PDAC planned to have neoadjuvant chemotherapy.
The MDT Discussion outcome document will clarify what the treatment plan is for each individual patient. If this plan documents ‘plan to receive neoadjuvant chemotherapy’ then that is a ‘yes’ to ‘plan to receive neoadjuvant therapy’. The proportion of patients who have this plan before and after the synoptic report is introduced for BR will be therefore calculated. In short, the primary source document (MDT discussion outcome) will provide the answer.

Timepoint [5]

At the time of the MDT

Secondary outcome [6]

Patients planned to receive neoadjuvant chemotherapy (yes/no). To determine the change in the proportion of patients with LA PDAC planned to have neoadjuvant chemotherapy.
The MDT Discussion outcome document will clarify what the treatment plan is for each individual patient. If this plan documents ‘plan to receive neoadjuvant chemotherapy’ then that is a ‘yes’ to ‘plan to receive neoadjuvant therapy’. The proportion of patients who have this plan before and after the synoptic report is introduced for LA will be therefore calculated. In short, the primary source document (MDT discussion outcome) will provide the answer.

Timepoint [6]

At the time of the MDT

Secondary outcome [7]

Patient undergoing R1 resection (yes/no). To determine the change in the proportion of patients undergoing R1 resection (microscopic margin positivity).
The information regarding whether a surgical margin is positive or not is documented and obtained from the anatomical pathology histopathological assessment of resected pancreas cancers, which is one of the primary data sources we gather.

Timepoint [7]

At the time of surgery (if undertaken)

Secondary outcome [8]

Patient undergoing R2 resection (yes/no). To determine the change in the proportion of patients undergoing R2 resection (macroscopic margin positivity).
The information regarding whether an R2 margin (gross tumour left at time of surgery) will be obtained from the surgical operation report provided as one of the primary data sources, which will be uploaded to the REDCap database.

Timepoint [8]

At the time of surgery (if undertaken)

Secondary outcome [9]

Patient's surgery is abandoned (yes/no). To determine the change in the proportion of patients whose surgery is abandoned.
Surgical operation report will provide this information (i.e. that a patient had a surgical resection intended, but that was abandoned and why).

Timepoint [9]

At the time of surgery (if undertaken)

Secondary outcome [10]

Patient's management strategy changed (yes, no). To determine the change in the management strategies for patients with CR, BR and LA PDAC.
Treatment patterns before and after for each group individual will be assessed.
The MDT Discussion outcome document (ie, the primary source document) will clarify what the treatment plan is for each individual patient and provide the answer. The management strategy documented will be compared before and after synoptic reporting.

Timepoint [10]

At the time of MDT

Secondary outcome [11]

atient's survival status. To determine the overall survival rate for patients with CR localised PC.
(Note: Survival rates for patients with CR cancer, rates for patients with BR cancer and rates for patients with LA disease will each be assessed independently.)

Timepoint [11]

6 months post completion of recruitment at end of trial

Secondary outcome [12]

Patient's survival status. To determine the overall survival rate for patients with BR localised PC.

Timepoint [12]

6 months post completion of recruitment at end of trial

Secondary outcome [13]

Patient's survival status. To determine the overall survival rate for patients with LA localised PC.

Timepoint [13]

6 months post completion of recruitment at end of trial

Secondary outcome [14]

To determine the satisfaction of radiologists and HPB (hepatobiliary) surgeons involved in this trial (to be determined using a standard survey tool which is designed specifically for this study)

Timepoint [14]

Prior to the introduction of synoptic reporting and 6 months post commencing synoptic reporting

Secondary outcome [15]

To determine the extent to which the synoptic reports for PC has become standard of care in routine MDT meetings and whether this model has been incorporated into in-house RIS/PACS (radiology information systems and picture archiving and communication systems).

This will be assessed by a query ‘are you still using synoptic reporting’ 6 months after trial complete which will be asked of each principal investigator at each site.

Timepoint [15]

6 months after trial complete

Eligibility

Key inclusion criteria

Health Services:
1. Hold a multidisciplinary team (MDT) meeting where PDAC cases are presented
2. Are prepared to be randomised
3. Manage on average 30 patients with PDAC annually (including but not limited to: use of chemotherapy, surgery, palliative care)
Within each health institution that is randomised, the study will assess the use of the synoptic reporting in people who meet the following criteria
1. Be aged 18 years of age or older;
2. Have suspected PDAC;
3. Have an abdominal CT scan (either performed by hospital radiology departments or an external radiology service) as a part of standard clinical care for diagnostic purposes; and
4. Are listed for discussion on the hepato-pancreato-biliary (HPB) multidisciplinary team (MDT) agenda of a participating site

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Institutions already using a synoptic radiological report as their primary reporting process for CT scans of suspected cases of PDAC.
No data will be collected from patients with neuroendocrine tumours.

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other

Other design features

Stepped wedge cluster randomised trial with sites randomised to the time at which they will commence use of the synoptic report.
This will be done on periods of length of 6 months.
Participating sites will start the study in 3 batches (about 12 hospitals in each batch); data collection in each batch starting up to 3 months after the start of the previous batch. In each batch, hospitals will be randomised to the sequences of the stepped wedge design. Initially all hospitals in the same batch will continue to use their current standard radiology reporting (the comparator); after each six-month period, a group of hospitals (depending on the sequence) will commence using the synoptic report template (the intervention), until all hospitals are using the synoptic report.

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Results will be reported according to the CONSORT extension for stepped wedge trials [19]. Baseline data will be presented in a tabular form with mean and standard deviation or median with lowest and highest values, or percentages and counts as appropriate, by treatment sequence and time period.
Results will be compared between standard reporting and synoptic reporting phases. All available primary and secondary outcomes will be analysed at the patient level using mixed-effects regression models with random intercepts for each cluster in each period, assuming a discrete time decay within-cluster correlation structure and a fixed effect for the intervention. Separate fixed effects for period for each batch will be included in the models, following the recommendation in a published research paper on batched stepped wedge design by Kasza et al in 2022 (Reference: DOI: 10.1002/sim.9438). For binary outcomes, log-binomial models will initially be fitted; should these fail to converge, mixed-effects Poisson regression models will be fitted, with robust variance estimation. Results will be presented as relative risks with 95% confidence intervals, and as risk differences with 95% confidence intervals. The sensitivity of results to the assumed within-cluster correlation structure will be assessed by fitting models with random effects for each cluster only. Estimated intracluster correlations will be reported. The survival outcome will be analysed using a Cox proportional hazards model including shared frailty terms for cluster. All tests will be two-sided with statistical significance defined as p < 0.05. Analyses will be conducted in Stata v 17 or later or in R version 4.2.1 or later as appropriate.
A statistical analysis plan will be prepared and finalised prior to the dataset being released to the statistician.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/07/2023

Actual

1/07/2023

Date of last participant enrolment

Anticipated

30/06/2026

Actual

Date of last data collection

Anticipated

31/12/2026

Actual

Sample size

Target

2400

Accrual to date

1360

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

The Canberra Hospital - Garran

Recruitment hospital [3]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [4]

John Hunter Hospital - New Lambton

Recruitment hospital [5]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [6]

The Prince Charles Hospital - Chermside

Recruitment hospital [7]

The Wesley Hospital - Auchenflower

Recruitment hospital [8]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [9]

Mater Hospital Pimlico - Pimlico

Recruitment hospital [10]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [11]

Royal Hobart Hospital - Hobart

Recruitment hospital [12]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [13]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [14]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [15]

Peninsula Private Hospital - Frankston - Frankston

Recruitment hospital [16]

The Northern Hospital - Epping

Recruitment hospital [17]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [18]

Concord Repatriation Hospital - Concord

Recruitment hospital [19]

Royal North Shore Hospital - St Leonards

Recruitment hospital [20]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [21]

Eastern Health - Box Hill

Recruitment hospital [22]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [23]

St Vincent's Private Hospital - Fitzroy

Recruitment hospital [24]

Western Hospital - Footscray - Footscray

Recruitment hospital [25]

Royal Perth Hospital - Perth

Recruitment hospital [26]

Westmead Rehabilitation Hospital - Merrylands

Recruitment hospital [27]

Prince of Wales Hospital - Randwick

Recruitment hospital [28]

The Townsville Hospital - Douglas

Recruitment hospital [29]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [30]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [31]

Epworth Richmond - Richmond

Recruitment hospital [32]

Wollongong Hospital - Wollongong

Recruitment hospital [33]

Epworth Freemasons (Clarendon Street) - East Melbourne

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

2605 - Garran

Recruitment postcode(s) [3]

4102 - Woolloongabba

Recruitment postcode(s) [4]

2305 - New Lambton

Recruitment postcode(s) [5]

2050 - Camperdown

Recruitment postcode(s) [6]

4032 - Chermside

Recruitment postcode(s) [7]

4066 - Auchenflower

Recruitment postcode(s) [8]

4575 - Birtinya

Recruitment postcode(s) [9]

4810 - Pimlico

Recruitment postcode(s) [10]

5011 - Woodville

Recruitment postcode(s) [11]

7000 - Hobart

Recruitment postcode(s) [12]

3000 - Melbourne

Recruitment postcode(s) [13]

3050 - Parkville

Recruitment postcode(s) [14]

3144 - Malvern

Recruitment postcode(s) [15]

3199 - Frankston

Recruitment postcode(s) [16]

3076 - Epping

Recruitment postcode(s) [17]

6150 - Murdoch

Recruitment postcode(s) [18]

2139 - Concord

Recruitment postcode(s) [19]

2065 - St Leonards

Recruitment postcode(s) [20]

4029 - Herston

Recruitment postcode(s) [21]

3128 - Box Hill

Recruitment postcode(s) [22]

3065 - Fitzroy

Recruitment postcode(s) [23]

3011 - Footscray

Recruitment postcode(s) [24]

6000 - Perth

Recruitment postcode(s) [25]

2160 - Merrylands

Recruitment postcode(s) [26]

2031 - Randwick

Recruitment postcode(s) [27]

4814 - Douglas

Recruitment postcode(s) [28]

5000 - Adelaide

Recruitment postcode(s) [29]

2200 - Bankstown

Recruitment postcode(s) [30]

3121 - Richmond

Recruitment postcode(s) [31]

2500 - Wollongong

Recruitment postcode(s) [32]

3002 - East Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government - Medical Research Future Fund (MRFF)

Address [1]

NHMRC:
Research Administration Section
National Health and Medical Research Council
GPO Box 1421
Canberra City ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Level 5, 553 St Kilda Road,
Melbourne, Victoria 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Metro North Hospital Health Service

Address [1]

Building 34, Level 1
Royal Brisbane and Women’s Hospital
1 Butterfield St, Herston QLD 4029

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Austin Health

Address [2]

Level 8, Harold Stokes Building, 145 Studley Road, Heidelberg.
Victoria, 3084

Country [2]

Australia

Other collaborator category [3]

University

Name [3]

Western Sydney University

Address [3]

Building BA, Ground Floor, Werrington North Campus, Great
Western Highway, Werrington NSW 2747

Country [3]

Australia

Other collaborator category [4]

Hospital

Name [4]

Sydney Local Health District as represented by Concord Repatriation General Hospital

Address [4]

Level 11, KGV Building, RPA Hospital, Missenden Road
Camperdown NSW 2050

Country [4]

Australia

Other collaborator category [5]

Hospital

Name [5]

Wollongong Hospital

Address [5]

ISLHD Executive Office, Suite 2, Level 2, 67-71 King Street,
Warrawong, NSW 2502 Australia

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Research Support Services
Level 2, i Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/09/2022

Approval date [1]

14/11/2022

Ethics approval number [1]

ERM Reference Number: 89841. Monash Health Reference: RES-22-0000-593A (and a revised HREC Review Only Approval letter with site names adjusted was issued on 18 April 2023 after a post-approval amendment submission).

Summary

Brief summary

People with PC are treated according to the extent of their disease at diagnosis. One of the problems that doctors face is adequately distinguishing patients who should receive chemotherapy before surgery versus surgery alone. This study aims to test whether a structured radiology report can improve the accuracy of reporting of CT scans in PC to optimise care.

Who is it for?
You may be eligible for this study if you are an adult who has suspected pancreatic cancer, you have an abdominal CT scan performed for diagnostic purposes and you are attending one of the participating hospitals for this study. 

Study details
Participants included in this study may either have their CT scan reviewed and reported using  standard radiology reporting as per usual practices, or using a more structured radiology reporting tool that is being tested for this study. The radiology reporting that participants receive will depend upon the hospital they are being treated at and the timing of their appointments; as all participating hospitals will be randomly allocated to start using the new radiology reporting tool at different times throughout the study. All participants will receive the best standard of care regardless of whether the hospital they are attending has been allocated to use the new reporting tool or not.

It is hoped this research will determine the usefulness and reliability of the new structured radiology reporting tool. If this study finds that using the structured tool leads to more accurate diagnosis of pancreatic cancer types that can then in turn optimise the treatment options available to patients, use of the reporting tool may be expanded to a greater number of hospitals.

Trial website

https://ugicr.org.au/scanpatient/

Trial related presentations / publications

The study has not yet commenced.

Public notes

Prior to the current clinical trial, a small scale pilot study on the topic was conducted in 2020-21, and the following is the link to a publication from that pilot study: https://pubmed.ncbi.nlm.nih.gov/36054233/.

Contacts

Principal investigator

Name

A/Prof Charles Pilgrim

Address

Cancer Research Program
Level 5, 553 St Kilda Road
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 4 27776697

Fax

[email protected]

Contact person for public queries

Name

Lin Li

Address

Cancer Research Program
Level 5, 553 St Kilda Road
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 3 9903 0378

Fax

[email protected]

Contact person for scientific queries

Name

John Zalcberg

Address

Cancer Research Program
Level 5, 553 St Kilda Road
Melbourne VIC 3004
Australia

Country

Australia

Phone

+61 3 9903 0388

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The privacy of individuals is of the utmost importance to researchers in this project. Data/results will only be reported in an aggregate form and every effort will be made to ensure individuals are not re-identifiable in research presentations or reports. Access to identifying information will be limited to only those who require it to conduct this study.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17666	Ethical approval			[email protected]		384749-(Uploaded-01-05-2023-14-30-27)-Study-related document.pdf

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

Documents added manually

Documents added automatically