Clinical Trial

IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN

Study acronym: IPEX
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07535125
Lead Sponsor A.O.U. Città della Salute e della Scienza
Conditions Intraductal Papillary Mucinous Neoplasms, Pancreatic Exocrine Insufficiency
Enrollment 600 participants
Start Date 2026-07-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-16