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NCT07535125Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
30 Mar 2026
Start date
1 Jul 2026
Primary completion date
31 Dec 2027
Lead sponsor
A.O.U. Città della Salute e della Scienza
NCT number
NCT07535125

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 1 Jul 2026 to the primary completion date, 31 Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior pancreatic surgery

Other

  • Chronic pancreatitis
  • Known pancreatic ductal adenocarcinoma at baseline
  • Other established causes of PEI unrelated to IPMN

Who the study is looking for

  • Age ≥18 years
  • Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN
  • Under active imaging surveillance
  • Signed informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.