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

NCT05450627 | Completed

• 1 other identifier: PEI-01-2021
• Study Type: observational
• Target: 1,015
• Locations: 1 country
• Sites: 1

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.

Conditions

Exocrine Pancreatic Insufficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose of oral pancreatic enzymes

  Dose required for symptoms relief and normalization of the nutritional status

  Six months

Study Arms (1)

Patients with PEI secondary to different etiologies

Adult patients diagnosed with pancreatic exocrine insufficiency secondary to chronic pancreatitis, pancreatic cancer, pancreatectomy, acute pancreatitis, and other stiologies.

Drug: Pancreatic Enzyme

Interventions

Pancreatic Enzyme DRUG

Registry of pancreatic enzyme therapy prescribed to included patients

Patients with PEI secondary to different etiologies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology.

You may qualify if:

• Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy.
• Willingness to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Instituto de Investigacion Sanitaria de Santiago de Compostela: collaborator

Study Sites (1)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatic Neoplasms; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• J. Enrique Dominguez-Munoz, Prof, PhD, MD

  University Hospital of Santiago de Compostela, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Gastroenterology

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: June 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 1 month and ending 1 year after the publication of results
• Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations

ES (1)