Intraductal Papillary Mucinous Neoplasms (IPMN) are pancreatic cystic neoplasms managed through imaging-based surveillance focused on oncologic risk. However, IPMN pathophysiology includes ductal obstruction by mucin, chronic ductal hypertension, and progressive parenchymal atrophy, mechanisms that may lead to pancreatic exocrine insufficiency (PEI).

PEI is a maldigestion syndrome typically associated with chronic pancreatitis, pancreatic cancer, and pancreatic surgery, but it has never been systematically investigated in patients with IPMN under surveillance.

The IPEX study is a multicenter prospective observational cohort study designed to evaluate whether PEI is prevalent in IPMN patients and whether it correlates with morphologic disease progression. The study also evaluates the potential role of PEI as a functional marker complementary to imaging criteria in IPMN surveillance.

progression in patients diagnosed with branch-duct, main-duct, or mixed-type IPMN undergoing routine surveillance.

PEI will be assessed using a composite clinical-biochemical definition based on fecal elastase-1 (FE-1) levels and standardized clinical evaluation through a pancreatology visit and PEI Symptom Score (PSS).

IPMN progression will be defined according to the development of worrisome features (WF), high-risk stigmata (HRS), need for intensified surveillance, referral to surgery, histologic high-grade dysplasia/carcinoma, or diagnosis of concomitant pancreatic ductal adenocarcinoma.

The study does not introduce any intervention beyond standard care and aims to determine whether PEI represents a marker of functional pancreatic deterioration associated with IPMN evolution.

Inclusion Criteria:

• Age ≥18 years
• Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN
• Under active imaging surveillance
• Signed informed consent

Exclusion Criteria:

• Prior pancreatic surgery
• Chronic pancreatitis
• Known pancreatic ductal adenocarcinoma at baseline
• Other established causes of PEI unrelated to IPMN

Patients undergoing routine surveillance for IPMN at participating centers.

Data obtained through this study may be provided to qualified researchers with academic interest in the topic. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Data will be available beginning 6-12 months after publication of the primary results and for up to 5 years thereafter.

Data sharing will require a formal data-sharing agreement and compliance with applicable data protection laws (e.g., GDPR).