SCANPatient: study protocol for a multi-centre, batched, stepped wedge, comparative effectiveness, randomised clinical trial of synoptic reporting of computerised tomography (CT) scans assessing cancers of the pancreas

• Published in: Current controlled trials in cardiovascular medicine 2024-06, Vol.25 (1), p.388-17
• Main Authors: Li, Lin, Kasza, Jessica, Recasens, Ariadna, Ioannou, Liane, Greenhill, Elysia, Merrett, Neil, Cavallucci, David, Ellis, Samantha, Madgwick, Helen, Ko, Hyun Soo, Chantrill, Lorraine, Loveday, Benjamin, Nikfarjam, Mehrdad, Croagh, Daniel, Yang, Jessica, Dwyer, Andrew, Zalcberg, John, Pilgrim, Charles
• Format: Article
• Language: English
• Subjects: Analysis; Australia; Carcinoma, Pancreatic Ductal - diagnostic imaging; Carcinoma, Pancreatic Ductal - pathology; Carcinoma, Pancreatic Ductal - surgery; Carcinoma, Pancreatic Ductal - therapy; Care and treatment; Chemotherapy; Clinical trials; Comparative Effectiveness Research; Computerised tomography (CT) scans; CT imaging; Development and progression; Diagnosis; Disease; Health care; Hospital patients; Hospitals; Humans; Medical research; Metastasis; Multicenter Studies as Topic; Objectives; Oncology; Pancreatectomy; Pancreatic cancer; Pancreatic ductal adenocarcinoma (PDAC); Pancreatic Neoplasms - diagnostic imaging; Pancreatic Neoplasms - pathology; Pancreatic Neoplasms - surgery; Patients; Pilot projects; Predictive Value of Tests; Preventive medicine; Public health; Radiology; Randomised controlled trial; Randomized Controlled Trials as Topic; Resectability; Standard of care; Study Protocol; Surgeons; Surgery; Synoptic reporting; Tomography; Tomography, X-Ray Computed; Tumors
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-08196-5

Complete surgical removal of pancreatic ductal adenocarcinoma (PDAC) is central to all curative treatment approaches for this aggressive disease, yet this is only possible in patients technically amenable to resection. Hence, an accurate assessment of whether patients are suitable for surgery is of paramount importance. The SCANPatient trial aims to test whether implementing a structured synoptic radiological report results in increased institutional accuracy in defining surgical resectability of non-metastatic PDAC. SCANPatient is a batched, stepped wedge, comparative effectiveness, cluster randomised clinical trial. The trial will be conducted at 33 Australian hospitals all of which hold regular multi-disciplinary team meetings (MDMs) to discuss newly diagnosed patients with PDAC. Each site is required to manage a minimum of 20 patients per year (across all stages). Hospitals will be randomised to begin synoptic reporting within a batched, stepped wedge design. Initially all hospitals will continue to use their current reporting method; within each batch, after each 6-month period, a randomly selected group of hospitals will commence using the synoptic reports, until all hospitals are using synoptic reporting. Each hospital will provide data from patients who (i) are aged 18 or older; (ii) have suspected PDAC and have an abdominal CT scan, and (iii) are presented at a participating MDM. Non-metastatic patients will be documented as one of the following categories: (1) locally advanced and surgically unresectable; (2) borderline resectable; or (3) anatomically clearly resectable (Note: Metastatic disease is treated as a separate category). Data collection will last for 36 months in each batch, and a total of 2400 patients will be included. Better classifying patients with non-metastatic PDAC as having tumours that are either clearly resectable, borderline or locally advanced and unresectable may improve patient outcomes by optimising care and treatment planning. The borderline resectable group are a small but important cohort in whom surgery with curative intent may be considered; however, inconsistencies with definitions and an understanding of resectability status means these patients are often incorrectly classified and hence overlooked for curative options. The SCANPatient trial was registered on 17th May 2023 in the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12623000508673).