Exocrine Pancreatic InsufficiencyEURO-PEI regisNCT05450627
Registry of Pancreatic Exocrine Insufficiency: Enzyme Dose Requirements and Outcomes in Pancreatic Exocrine Insufficiency Across Aetiologies
An observational study of Exocrine Pancreatic Insufficiency, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
EURO-PEI is a multicentre, observational registry conducted at eight specialist pancreatic centres in Spain, Hungary, France, Italy, and the United Kingdom. The registry was designed to capture routine specialist practice without protocol-mandated diagnostic testing, PERT dosing, proton pump inhibitor (PPI) use, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency
- What is being tested?
- Pancreatic Enzyme
- How many people
- 1,015 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 30 Sep 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology.
Who may be able to join
- Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy.
- Willingness to participate in the study.
Who cannot join
- Patients with pancreatic diseases without PEI.
- Pregnancy
- Known allergy to oral pancreatic enzymes
- Any condition avoiding adequate clinical management of PEI.
- Patients who are not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
About this study
Official title: Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies: EURO-PEI Registry
EURO-PEI is a multicentre, observational registry conducted at eight specialist pancreatic centres in Spain, Hungary, France, Italy, and the United Kingdom. The registry was designed to capture routine specialist practice without protocol-mandated diagnostic testing, PERT dosing, proton pump inhibitor (PPI) use, or follow-up intervals. Adults aged 18 years or older are eligible if they have a clinician-established diagnosis of PEI and PERT is initiated or actively managed during specialist follow-up. Patients already receiving PERT at registry inclusion, including those entered from any pre-existing database, are eligible if the diagnosis of PEI and the indication for ongoing treatment are confirmed by the treating specialist. Patients may have acute pancreatitis, chronic pancreatitis, cystic fibrosis, pancreatic cancer, pancreatectomy, or other pancreatic or extrapancreatic conditions potentially leading to PEI.
- Conditions
- Exocrine Pancreatic Insufficiency
- Being tested
- Pancreatic Enzyme
- Keywords
- pancreatic exocrine insufficiency, pancreatic enzyme replacement therapy, dose optimisation, pancreatectomy, pancreatic cancer, chronic pancreatitis, real-world evidence
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatic Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic EnzymeDrug
Registry of pancreatic enzyme therapy prescribed to included patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with PEI secondary to different etiologies | Adult patients diagnosed with pancreatic exocrine insufficiency secondary to chronic pancreatitis, pancreatic cancer, pancreatectomy, acute pancreatitis, and other stiologies. Receives: Drug: Pancreatic Enzyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of oral pancreatic enzymes
Dose required for symptoms relief and normalization of the nutritional status
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jun 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic InsufficiencyStudies 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
- 1,015 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria de Santiago de Compostela
- Responsible party
- Principal investigator, J. Enrique Domínguez-Muñoz, Hospital Clinico Universitario de Santiago
- Investigators
- J. Enrique Dominguez-Munoz, Prof, PhD, MD, Principal investigator, University Hospital of Santiago de Compostela, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450627
- Sponsor's protocol ID
- PEI-01-2021
- Acronym
- EURO-PEI regis
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies: EURO-PEI Registry
- ClinicalTrials.gov ID
- NCT05450627
- Acronym / sponsor ID
- EURO-PEI regis / PEI-01-2021
- Conditions
- Exocrine Pancreatic Insufficiency
- Keywords
- pancreatic exocrine insufficiency, pancreatic enzyme replacement therapy, dose optimisation, pancreatectomy, pancreatic cancer, chronic pancreatitis, real-world evidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria de Santiago de Compostela
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Jul 2022 (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.
EURO-PEI is a multicentre, observational registry conducted at eight specialist pancreatic centres in Spain, Hungary, France, Italy, and the United Kingdom. The registry was designed to capture routine specialist practice without protocol-mandated diagnostic testing, PERT dosing, proton pump inhibitor (PPI) use, or follow-up intervals. Adults aged 18 years or older are eligible if they have a clinician-established diagnosis of PEI and PERT is initiated or actively managed during specialist follow-up. Patients already receiving PERT at registry inclusion, including those entered from any pre-existing database, are eligible if the diagnosis of PEI and the indication for ongoing treatment are confirmed by the treating specialist. Patients may have acute pancreatitis, chronic pancreatitis, cystic fibrosis, pancreatic cancer, pancreatectomy, or other pancreatic or extrapancreatic conditions potentially leading to PEI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PEI secondary to different etiologies | – | Drug: Pancreatic EnzymeAdult patients diagnosed with pancreatic exocrine insufficiency secondary to chronic pancreatitis, pancreatic cancer, pancreatectomy, acute pancreatitis, and other stiologies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology.
Key inclusion criteria (2 listed)
- Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy.
- Willingness to participate in the study.
Key exclusion criteria (5 listed)
- Patients with pancreatic diseases without PEI.
- Pregnancy
- Known allergy to oral pancreatic enzymes
- Any condition avoiding adequate clinical management of PEI.
- Patients who are not willing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancreatic EnzymeRegistry of pancreatic enzyme therapy prescribed to included patients | Drug | Patients with PEI secondary to different etiologies |
Primary outcome
Dose of oral pancreatic enzymes
Time frame: Six months
Dose required for symptoms relief and normalization of the nutritional status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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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. This study is not recruiting at the moment.
J. Enrique Dominguez-Munoz, Prof, PhD, MD principal investigator
University Hospital of Santiago de Compostela, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exocrine Pancreatic Insufficiency, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of oral pancreatic enzymes (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.