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

Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies: EURO-PEI Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05450627

Acronym

EURO-PEI regis

Enrollment

1015

Registered

2022-07-11

Start date

2021-06-01

Completion date

2025-09-30

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exocrine Pancreatic Insufficiency

Keywords

pancreatic exocrine insufficiency, pancreatic enzyme replacement therapy, dose optimisation, pancreatectomy, pancreatic cancer, chronic pancreatitis, real-world evidence

Brief 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.

Interventions

DRUGPancreatic Enzyme

Registry of pancreatic enzyme therapy prescribed to included patients

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Dose of oral pancreatic enzymes	Six months	Dose required for symptoms relief and normalization of the nutritional status

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORJ. Enrique Dominguez-Munoz, Prof, PhD, MD

University Hospital of Santiago de Compostela, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026