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Completed
NCT05450627
Registry of Pancreatic Exocrine Insufficiency: Enzyme Dose Requirements and Outcomes in Pancreatic Exocrine Insufficiency Across Aetiologies
Conditions: Exocrine Pancreatic Insufficiency
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1015
Sponsor: Hospital Clinico Universitario de Santiago
Location: Hospital Clinico Universitario de Santiago Santiago de Compostela A Coruña
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05450627). StuddyBuddy aggregates publicly available trial information.