Biomarkers and Imaging to Identify High-Grade Dysplasia and Invasive Carcinoma in Pancreatic Intraductal Papillary Mucinous Neoplasms

What this Trial Is About

Researchers are evaluating biomarkers and imaging methods to better identify high-grade dysplasia and invasive carcinoma in patients with intraductal papillary mucinous neoplasms IPMN of the pancreas. This study aims to improve patient selection to reduce overtreatment and distinguish benign IPMNs from those with higher cancer risk by examining endocrine, metabolic, and inflammatory profiles. The study has three main goals to validate updated international and European guidelines retrospectively, to identify biomarkers in a prospective patient group, and to validate these biomarkers in a new surgical cohort. The study includes three cohorts a retrospective group of 350 patients with resected IPMN analyzed to validate guideline accuracy a prospective observational cohort of 186 patients 145 undergoing surgery to identify biological and imaging biomarkers using MRI and endoscopic ultrasound EUS and a third prospective cohort of 50 patients to validate the identified biomarkers. Imaging assessments focus on features such as main pancreatic duct involvement and surrounding tissue characteristics. Patients undergo standard pre-operative MRI and EUS exams within a three-month window. Participants are involved through retrospective data review or prospective enrollment with informed consent. Assessments include clinical, radiological, and biological evaluations, with follow-up to measure endocrine, metabolic, and inflammatory profiles and imaging biomarkers. Outcomes focus on guideline accuracy, biomarker effectiveness in predicting pathology, and comparison of MRI versus EUS accuracy. The study is observational and does not involve investigational treatments, with participation lasting up to 12 months depending on cohort and follow-up schedule.

Endocrine, Metabolic, Inflammatory Biomarkers to Identify Highgrade Dysplasia/invasive Carcinoma in Patients with IPMN of the Pancreas