Intraductal Papillary Mucinous Neoplasms, Pancreatic Exocrine Insufficiency
Conditions
Keywords
Functional Marker, pancreatic exocrine insufficiency, Intraductal Papillary Mucinous Neoplasms
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between clinically relevant PEI and IPMN progression during follow-up | Day 1 and after 6 and 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence and incidence of PEI in IPMN patients | Day 1 and after 6 and 12 months | — |
| Association between imaging parameters (MPD diameter, parenchymal atrophy) and PEI | Day 1 and after 6 and 12 months | — |
| Time-to-progression stratified by PEI status | Day 1 and after 6 and 12 months | — |
| Nutritional impact of PEI | Day 1 and after 6 and 12 months | Weight loss |
| Incremental predictive value of PEI beyond imaging criteria | Day 1 and after 6 and 12 months | — |
Contacts
CONTACTGiacomo Deiro, MD
PRINCIPAL_INVESTIGATORGiacomo Deiro, MD
A.O.U. Città della Salute e della Scienza
Outcome results
None listed