The Trivial IPMN Trial: An International, non-randomized, single-arm trial on surveillance discontinuation in stable lesions after 5 years

Background Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal human malignancies, with an overall survival of around 10% in 5 years. Approximately 20% of PDAC originate from precursor pancreatic lesions called BD-IPMN (Branch Duct Intraductal Papillary Mucinous Neoplasm). The degeneration of an BD-IPMN into pancreatic adenocarcinoma is a rare event; approximately 2% of these cysts undergo this process. However, given such a grim prognosis, all patients with pancreatic cysts are currently subjected to lifelong follow-up, with MRI imaging, blood tests and an outpatient surgical visit in order to detect and treat PDAC in early stage. Recent retrospective epidemiological studies suggest that it is possible to create a subcategory of BD-IPMNs, called TRIVIAL cysts. These lesions, if properly identified through specific parameters, do not carry a higher risk of developing pancreatic adenocarcinoma than individuals without pancreatic cystic lesions in the general population. Based on this, TRIVIAL cysts would therefore be eligible for discontinuation of follow-up, resulting in cost and management savings. This conclusion, however, has been contested by many experts in the field, as it contradicts the current management of these lesions and, above all, lacks prospective studies to demonstrate it. Aim The goal of the TRIVIAL TRIAL is to provide prospective data on the rate of pancreatic adenocarcinoma progression in patients with TRIVIAL IPMN. Since the final results of this study will be available in no less than 5 years, a case-control study is also being conducted in the meantime, based on the experience of the Hepatobiliary Pancreatic Unit at the University Hospital of Padua. This will statistically analyze the incidence of pancreatic adenocarcinoma in all patients who could have been defined as TRIVIAL patients.