An observational study in Intraductal Papillary Mucinous Neoplasms and Pancreatic Exocrine Insufficiency, sponsored by A.O.U. Città della Salute e della Scienza. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by A.O.U. Città della Salute e della Scienza · Observational
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.
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.
136 studies on the registry are indexed under Exocrine Pancreatic Insufficiency; 26 are open to participants now.
This study's planned enrollment of 600 is above the median of 120 across 38 observational studies indexed under Exocrine Pancreatic Insufficiency.
Browse Exocrine Pancreatic Insufficiency studies →A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing routine surveillance for IPMN at participating centers.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study includes a single prospective observational cohort of adult patients (≥18 years) with a diagnosis of intraductal papillary mucinous neoplasm (IPMN)-including branch-duct, main-duct, or mixed-type. Participants are managed according to standard-of-care IPMN surveillance protocols (MRI/MRCP ± EUS), with no mandated interventional treatment. In parallel, patients undergo a structured pancreatology assessment to evaluate pancreatic exocrine function. The exposure of interest is pancreatic exocrine insufficiency (PEI), defined using a composite clinical-biochemical criterion based on fecal elastase-1 (FE-1) levels and standardized clinical and nutritional parameters. No experimental intervention is administered; initiation of pancreatic enzyme replacement therapy (PERT), when clinically indicated, is recorded but not protocol-driven.
Association between clinically relevant PEI and IPMN progression during follow-up
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
Time frame: Day 1 and after 6 and 12 months
Prevalence and incidence of PEI in IPMN patients
Time frame: Day 1 and after 6 and 12 months
Association between imaging parameters (MPD diameter, parenchymal atrophy) and PEI
Time frame: Day 1 and after 6 and 12 months
Time-to-progression stratified by PEI status
Time frame: Day 1 and after 6 and 12 months
Nutritional impact of PEI
Weight loss
Time frame: Day 1 and after 6 and 12 months
Incremental predictive value of PEI beyond imaging criteria
Time frame: Day 1 and after 6 and 12 months
No study locations are listed for this record.
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in the topic. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6-12 months after publication of the primary results and for up to 5 years thereafter.
Access criteria: Data sharing will require a formal data-sharing agreement and compliance with applicable data protection laws (e.g., GDPR).
Start is estimated for Jul 2026; primary completion for Dec 2027, 17 months later.
Of 16 observational studies under Exocrine Pancreatic Insufficiency, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 79. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Exocrine Pancreatic Insufficiency →
A.O.U. Città della Salute e della Scienza