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