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NOT YET RECRUITING
NCT07535125

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

Sponsor: A.O.U. Città della Salute e della Scienza

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2026-07-01

Completion Date

2027-12-31

Last Updated

2026-04-16

Healthy Volunteers

No