Under the hypotheses that a more accurate patients selection could limit the problem of overtreatment and that benign intraductal papillary mucinous neoplasms (IPMN) have a distinguishable Endocrine/Metabolic/Inflammatory (EMI) profile from those with high-grade disease/invasive carcinoma, this study has three specific aims. The first aim is to evaluate and confirm the accuracy of the updated versions of International and European guidelines for the management of IPMN and it will be addressed by retrospectively applying the criteria included in the two guidelines on 350 patients with resected IPMN in order to determine the most accurate criteria to identify High Grade Dysplasia(HGD)/Invasive Carcinoma (IC).
The second aim is to identify pre-operative biological and/or radiological/endosonographic biomarker(s) able to distinguish low- versus high-risk IPMN for cancer progression in a prospective study by enrolling a cohort of 186 (of which 145 surgically-resected) patients.
The third aim is to prospectively validate biological and/or radiological/endosonographic biomarker(s) (previously identified and optimized) on a new cohort of 50 patients with IPMN undergoing surgical resection.
histologically proven IPMNs with full pathological data (type of IPMNs, grade of dysplasia; for invasive IPMNs: grading, pTNM classification, presence of perineural (microvascular infiltration)
availability of clinical and imaging criteria for surgical resections defined by International and European guidelines (worrisome features and high-risk stigmata according to International Guidelines and absolute/relative criteria for surgery according to European guidelines
age ≥18 years
Age >= 18 years
Charlson comorbidity index <7
indication for surgery for suspected IPMN
The patients will be enrolled in the outpatient clinic, if they meet the required criteria for inclusion.
Cohort
Prospective
Not listed
evaluation of the best guideline between the International and European guidelines
The criteria included in the two guidelines will be retrospectively applied on 350 patients with resected IPMN. Clinical pathological and imaging data will be retrieved from institutional archives systems. As we may be not able to identify a more accurate guideline, we may select specific criteria from each of the two guidelines, thus selecting p batients for surgery based on a combination of criteria from both guidelines. The identified best criteria will be applied to select the discovery cohort and the validation cohort of the prospective studies.
endocrine, metabolic and inflammatory profile
The following parameters will be measured in peripheral and portal serum/plasma and in the cyst fluid with commercially available kits
imaging-based biomarker(s)
As per standard-of-care current clinical practice in our institution, all patients will undergo 1.5T contrast-enhanced MR cholangiopancreatography (MRCP) with 3D acquisition protocol of the pancreatic ducts/ biliary tree
evaluation of the accuracy of the biomarkers in predicting the pathological diagnosis
the accuracy at identifying malignant IPMN of the identified biomarkers will be tested.
evaluation of the accuracy of the MRI versus the EUSP in identifying the involvement of the main pancreatic duct
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