None listed
Conditions
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.
Interventions
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
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed