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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorA.O.U. Città della Salute e della Scienza

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18 years

Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN

Under active imaging surveillance

Signed informed consent

Disqualifiers

Prior pancreatic surgery

Chronic pancreatitis

Known pancreatic ductal adenocarcinoma at baseline

Other established causes of PEI unrelated to IPMN

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

600 Participants
are grouped into 1 trial group

Locations

This trial has no locations