CompletedNot Applicable

Registry of Pancreatic Exocrine Insufficiency: Enzyme Dose Requirements and Outcomes in Pancreatic Exocrine Insufficiency Across Aetiologies

Spain1,015 participantsStarted 2021-06-01

Plain-language 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 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy. * Willingness to participate in the study. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose of oral pancreatic enzymes

Timeframe: Six months

Trial details

NCT IDNCT05450627

SponsorHospital Clinico Universitario de Santiago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Exocrine Pancreatic Insufficiency trials