Trial Review

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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] 308084 0
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 327772 0
Condition category
Condition code
Cancer 324842 324842 0 0
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] 324531 0
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] 332656 0
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] 332656 0
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] 414273 0
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] 414273 0
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] 414274 0
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] 414274 0
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 [3] 414275 0
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] 414275 0
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 [4] 414276 0
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] 414276 0
At the time of the MDT
Secondary outcome [5] 414277 0
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] 414277 0
At the time of the MDT
Secondary outcome [6] 414278 0
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] 414278 0
At the time of the MDT
Secondary outcome [7] 421678 0
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] 421678 0
At the time of surgery (if undertaken)
Secondary outcome [8] 421679 0
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] 421679 0
At the time of surgery (if undertaken)
Secondary outcome [9] 421680 0
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] 421680 0
At the time of surgery (if undertaken)
Secondary outcome [10] 421681 0
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] 421681 0
At the time of MDT
Secondary outcome [11] 421682 0
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] 421682 0
6 months post completion of recruitment at end of trial
Secondary outcome [12] 421683 0
Patient's survival status. To determine the overall survival rate for patients with BR localised PC.
Timepoint [12] 421683 0
6 months post completion of recruitment at end of trial
Secondary outcome [13] 421684 0
Patient's survival status. To determine the overall survival rate for patients with LA localised PC.
Timepoint [13] 421684 0
6 months post completion of recruitment at end of trial
Secondary outcome [14] 421685 0
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] 421685 0
Prior to the introduction of synoptic reporting and 6 months post commencing synoptic reporting
Secondary outcome [15] 421686 0
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] 421686 0
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?
No
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] 23271 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 23592 0
The Canberra Hospital - Garran
Recruitment hospital [3] 23593 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 23594 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 23595 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 23596 0
The Prince Charles Hospital - Chermside
Recruitment hospital [7] 23597 0
The Wesley Hospital - Auchenflower
Recruitment hospital [8] 23598 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [9] 23599 0
Mater Hospital Pimlico - Pimlico
Recruitment hospital [10] 23600 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [11] 23603 0
Royal Hobart Hospital - Hobart
Recruitment hospital [12] 23604 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [13] 23605 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [14] 23606 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [15] 23607 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [16] 23609 0
The Northern Hospital - Epping
Recruitment hospital [17] 23610 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [18] 24419 0
Concord Repatriation Hospital - Concord
Recruitment hospital [19] 24420 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [20] 24421 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [21] 24425 0
Eastern Health - Box Hill
Recruitment hospital [22] 24426 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [23] 24427 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [24] 24428 0
Western Hospital - Footscray - Footscray
Recruitment hospital [25] 24430 0
Royal Perth Hospital - Perth
Recruitment hospital [26] 24431 0
Westmead Rehabilitation Hospital - Merrylands
Recruitment hospital [27] 24432 0
Prince of Wales Hospital - Randwick
Recruitment hospital [28] 24433 0
The Townsville Hospital - Douglas
Recruitment hospital [29] 24434 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [30] 24683 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [31] 24684 0
Epworth Richmond - Richmond
Recruitment hospital [32] 25679 0
Wollongong Hospital - Wollongong
Recruitment hospital [33] 27275 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment postcode(s) [1] 38640 0
3168 - Clayton
Recruitment postcode(s) [2] 39012 0
2605 - Garran
Recruitment postcode(s) [3] 39013 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 39014 0
2305 - New Lambton
Recruitment postcode(s) [5] 39015 0
2050 - Camperdown
Recruitment postcode(s) [6] 39016 0
4032 - Chermside
Recruitment postcode(s) [7] 39017 0
4066 - Auchenflower
Recruitment postcode(s) [8] 39018 0
4575 - Birtinya
Recruitment postcode(s) [9] 39019 0
4810 - Pimlico
Recruitment postcode(s) [10] 39020 0
5011 - Woodville
Recruitment postcode(s) [11] 39022 0
7000 - Hobart
Recruitment postcode(s) [12] 39023 0
3000 - Melbourne
Recruitment postcode(s) [13] 39024 0
3050 - Parkville
Recruitment postcode(s) [14] 39025 0
3144 - Malvern
Recruitment postcode(s) [15] 39026 0
3199 - Frankston
Recruitment postcode(s) [16] 39028 0
3076 - Epping
Recruitment postcode(s) [17] 39029 0
6150 - Murdoch
Recruitment postcode(s) [18] 40002 0
2139 - Concord
Recruitment postcode(s) [19] 40003 0
2065 - St Leonards
Recruitment postcode(s) [20] 40004 0
4029 - Herston
Recruitment postcode(s) [21] 40006 0
3128 - Box Hill
Recruitment postcode(s) [22] 40007 0
3065 - Fitzroy
Recruitment postcode(s) [23] 40008 0
3011 - Footscray
Recruitment postcode(s) [24] 40010 0
6000 - Perth
Recruitment postcode(s) [25] 40011 0
2160 - Merrylands
Recruitment postcode(s) [26] 40012 0
2031 - Randwick
Recruitment postcode(s) [27] 40013 0
4814 - Douglas
Recruitment postcode(s) [28] 40014 0
5000 - Adelaide
Recruitment postcode(s) [29] 40303 0
2200 - Bankstown
Recruitment postcode(s) [30] 40304 0
3121 - Richmond
Recruitment postcode(s) [31] 41504 0
2500 - Wollongong
Recruitment postcode(s) [32] 43362 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 312334 0
Government body
Name [1] 312334 0
Australian Government - Medical Research Future Fund (MRFF)
Country [1] 312334 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 5, 553 St Kilda Road,
Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 315195 0
None
Name [1] 315195 0
Address [1] 315195 0
Country [1] 315195 0
Other collaborator category [1] 282491 0
Hospital
Name [1] 282491 0
Metro North Hospital Health Service
Address [1] 282491 0
Building 34, Level 1
Royal Brisbane and Women’s Hospital
1 Butterfield St, Herston QLD 4029
Country [1] 282491 0
Australia
Other collaborator category [2] 282492 0
Hospital
Name [2] 282492 0
Austin Health
Address [2] 282492 0
Level 8, Harold Stokes Building, 145 Studley Road, Heidelberg.
Victoria, 3084
Country [2] 282492 0
Australia
Other collaborator category [3] 282493 0
University
Name [3] 282493 0
Western Sydney University
Address [3] 282493 0
Building BA, Ground Floor, Werrington North Campus, Great
Western Highway, Werrington NSW 2747
Country [3] 282493 0
Australia
Other collaborator category [4] 282494 0
Hospital
Name [4] 282494 0
Sydney Local Health District as represented by Concord Repatriation General Hospital
Address [4] 282494 0
Level 11, KGV Building, RPA Hospital, Missenden Road
Camperdown NSW 2050
Country [4] 282494 0
Australia
Other collaborator category [5] 282495 0
Hospital
Name [5] 282495 0
Wollongong Hospital
Address [5] 282495 0
ISLHD Executive Office, Suite 2, Level 2, 67-71 King Street,
Warrawong, NSW 2502 Australia
Country [5] 282495 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311702 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 311702 0
Ethics committee country [1] 311702 0
Australia
Date submitted for ethics approval [1] 311702 0
28/09/2022
Approval date [1] 311702 0
14/11/2022
Ethics approval number [1] 311702 0
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122054 0
A/Prof Charles Pilgrim
Address 122054 0
Cancer Research Program
Level 5, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country 122054 0
Australia
Phone 122054 0
+61 4 27776697
Fax 122054 0
Email 122054 0
charlespilgrim@hotmail.com
Contact person for public queries
Name 122055 0
Lin Li
Address 122055 0
Cancer Research Program
Level 5, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country 122055 0
Australia
Phone 122055 0
+61 3 9903 0378
Fax 122055 0
Email 122055 0
lin.li1@monash.edu
Contact person for scientific queries
Name 122056 0
John Zalcberg
Address 122056 0
Cancer Research Program
Level 5, 553 St Kilda Road
Melbourne VIC 3004
Australia
Country 122056 0
Australia
Phone 122056 0
+61 3 9903 0388
Fax 122056 0
Email 122056 0
john.zalcberg@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
17666Ethical approval  scanpatient@monash.edu 384749-(Uploaded-01-05-2023-14-30-27)-Study-related document.pdf



Results publications and other study-related documents

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