Intraductal Papillary Mucinous NeoplasmsIPEXNCT07535125
IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN
An observational study of Intraductal Papillary Mucinous Neoplasms and Pancreatic Exocrine Insufficiency, run by A.O.U. Città della Salute e della Scienza.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraductal Papillary Mucinous Neoplasms, Pancreatic Exocrine Insufficiency
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing routine surveillance for IPMN at participating centers.
Who may be able to join
- Age ≥18 years
- Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN
- Under active imaging surveillance
- Signed informed consent
Who cannot join
- Prior pancreatic surgery
- Chronic pancreatitis
- Known pancreatic ductal adenocarcinoma at baseline
- Other established causes of PEI unrelated to IPMN
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN Under Surveillance
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.
Read the detailed description
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.
- Keywords
- Functional Marker, pancreatic exocrine insufficiency, Intraductal Papillary Mucinous Neoplasms
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IPMN | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 and after 6 and 12 months
Secondary outcomes (5)
Prevalence and incidence of PEI in IPMN patients
Measured: Day 1 and after 6 and 12 months
Association between imaging parameters (MPD diameter, parenchymal atrophy) and PEI
Measured: Day 1 and after 6 and 12 months
Time-to-progression stratified by PEI status
Measured: Day 1 and after 6 and 12 months
Nutritional impact of PEI
Weight loss
Measured: Day 1 and after 6 and 12 months
Incremental predictive value of PEI beyond imaging criteria
Measured: Day 1 and after 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraductal Papillary Mucinous NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacomo Deiro, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535125
- Sponsor's protocol ID
- IPEX
- Acronym
- IPEX
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ohtsuka T, Fernandez-Del Castillo C, Furukawa T, Hijioka S, Jang JY, Lennon AM, Miyasaka Y, Ohno E, Salvia R, Wolfgang CL, Wood LD. International evidence-based Kyoto guidelines for the management of intraductal papillary mucinous neoplasm of the pancreas. Pancreatology. 2024 Mar;24(2):255-270. doi: 10.1016/j.pan.2023.12.009. Epub 2023 Dec 28.
PubMed 38182527Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.
PubMed 22687371Dominguez-Munoz JE, Vujasinovic M, de la Iglesia D, Cahen D, Capurso G, Gubergrits N, Hegyi P, Hungin P, Ockenga J, Paiella S, Perkhofer L, Rebours V, Rosendahl J, Salvia R, Scheers I, Szentesi A, Bonovas S, Piovani D, Lohr JM; European PEI Multidisciplinary Group. European guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency: UEG, EPC, EDS, ESPEN, ESPGHAN, ESDO, and ESPCG evidence-based recommendations. United European Gastroenterol J. 2025 Feb;13(1):125-172. doi: 10.1002/ueg2.12674. Epub 2024 Dec 5.
PubMed 39639485
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPEX Study: Pancreatic Exocrine Insufficiency as a Functional Marker of Disease Progression in Patients With IPMN Under Surveillance
- ClinicalTrials.gov ID
- NCT07535125
- Acronym / sponsor ID
- IPEX / IPEX
- Keywords
- Functional Marker, pancreatic exocrine insufficiency, Intraductal Papillary Mucinous Neoplasms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPMN | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing routine surveillance for IPMN at participating centers.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Diagnosis of BD-IPMN, MD-IPMN, or mixed IPMN
- Under active imaging surveillance
- Signed informed consent
Key exclusion criteria (4 listed)
- Prior pancreatic surgery
- Chronic pancreatitis
- Known pancreatic ductal adenocarcinoma at baseline
- Other established causes of PEI unrelated to IPMN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 38182527Ohtsuka T, Fernandez-Del Castillo C, Furukawa T, Hijioka S, Jang JY, Lennon AM, Miyasaka Y, Ohno E, Salvia R, Wolfgang CL, Wood LD. International evidence-based Kyoto guidelines for the management of intraductal papillary mucinous neoplasm of the pancreas. Pancreatology. 2024 Mar;24(2):255-270. doi: 10.1016/j.pan.2023.12.009. Epub 2023 Dec 28.
- Results publication: PubMed 22687371Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.
- Results publication: PubMed 39639485Dominguez-Munoz JE, Vujasinovic M, de la Iglesia D, Cahen D, Capurso G, Gubergrits N, Hegyi P, Hungin P, Ockenga J, Paiella S, Perkhofer L, Rebours V, Rosendahl J, Salvia R, Scheers I, Szentesi A, Bonovas S, Piovani D, Lohr JM; European PEI Multidisciplinary Group. European guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency: UEG, EPC, EDS, ESPEN, ESPGHAN, ESDO, and ESPCG evidence-based recommendations. United European Gastroenterol J. 2025 Feb;13(1):125-172. doi: 10.1002/ueg2.12674. Epub 2024 Dec 5.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giacomo Deiro, MD principal investigator
A.O.U. Città della Salute e della Scienza
Questions about this trial
What is this clinical trial studying?
An observational study of Intraductal Papillary Mucinous Neoplasms and Pancreatic Exocrine Insufficiency, run by A.O.U. Città della Salute e della Scienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Deiro, MD (+393489818794, giacomo.deiro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between clinically relevant PEI and IPMN progression during follow-up (time frame: Day 1 and after 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535125, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.