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.
Age ≥18 years
Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN
Under active imaging surveillance
Signed informed consent
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.
Cohort
Prospective
Not listed
Association between clinically relevant PEI and IPMN progression during follow-up
Clinically relevant PEI defined as: * FE-1 \<100 µg/g OR * FE-1 100-200 µg/g plus ≥1 clinical criterion IPMN progression defined by WF/HRS development, surgical referral, or histologic progression
Prevalence and incidence of PEI in IPMN patients
Association between imaging parameters (MPD diameter, parenchymal atrophy) and PEI
Time-to-progression stratified by PEI status
Nutritional impact of PEI
Weight loss
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