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

NCT05450627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1015

Last updated 2026-06-22

No results posted yet for this study

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.

Conditions

  • Exocrine Pancreatic Insufficiency

Interventions

DRUG

Pancreatic Enzyme

Registry of pancreatic enzyme therapy prescribed to included patients

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria de Santiago de Compostela

    collaborator UNKNOWN

  • Hospital Clinico Universitario de Santiago

    lead OTHER

Principal Investigators

  • J. Enrique Dominguez-Munoz, Prof, PhD, MD · University Hospital of Santiago de Compostela, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450627 on ClinicalTrials.gov