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NCT Number: NCT07535125

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

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.

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Key information

Conditions

Intraductal Papillary Mucinous Neoplasms Digestive System Diseases Exocrine Pancreatic Insufficiency Pancreatic Diseases Pancreatic Exocrine Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

progression in patients diagnosed with branch-duct, main-duct, or mixed-type IPMN undergoing routine surveillance.

PEI will be assessed using a composite clinical-biochemical definition based on fecal elastase-1 (FE-1) levels and standardized clinical evaluation through a pancreatology visit and PEI Symptom Score (PSS).

IPMN progression will be defined according to the development of worrisome features (WF), high-risk stigmata (HRS), need for intensified surveillance, referral to surgery, histologic high-grade dysplasia/carcinoma, or diagnosis of concomitant pancreatic ductal adenocarcinoma.

The study does not introduce any intervention beyond standard care and aims to determine whether PEI represents a marker of functional pancreatic deterioration associated with IPMN evolution.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Association between clinically relevant PEI and IPMN progression during follow-up

    Time frame: Day 1 and after 6 and 12 months

    Clinically relevant PEI defined as:

    • FE-1 <100 µg/g OR
    • FE-1 100-200 µg/g plus ≥1 clinical criterion IPMN progression defined by WF/HRS development, surgical referral, or histologic progression

Secondary outcomes

  1. Prevalence and incidence of PEI in IPMN patients

    Time frame: Day 1 and after 6 and 12 months

  2. Association between imaging parameters (MPD diameter, parenchymal atrophy) and PEI

    Time frame: Day 1 and after 6 and 12 months

  3. Time-to-progression stratified by PEI status

    Time frame: Day 1 and after 6 and 12 months

  4. Nutritional impact of PEI

    Time frame: Day 1 and after 6 and 12 months

    Weight loss

  5. Incremental predictive value of PEI beyond imaging criteria

    Time frame: Day 1 and after 6 and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Giacomo Deiro, MD

CONTACT

[email protected]

+393489818794

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: IPEX

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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