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

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.

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Key information

Conditions

Exocrine Pancreatic Insufficiency Chronic Disease Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pancreatic Enzyme

Drug

Registry of pancreatic enzyme therapy prescribed to included patients

Primary outcomes

Dose of oral pancreatic enzymes

Time frame: Six months

Dose required for symptoms relief and normalization of the nutritional status

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Collaborators

Instituto de Investigacion Sanitaria de Santiago de Compostela

Registry information

Official study title

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

Acronym: EURO-PEI regis

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Jul 11, 2022
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed