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CompletedNCT05450627EURO-PEI regisUpdated Jun 22, 2026

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

An observational study in Exocrine Pancreatic Insufficiency, sponsored by Hospital Clinico Universitario de Santiago. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Hospital Clinico Universitario de Santiago · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,015
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Exocrine Pancreatic Insufficiency

Keywords

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

Exocrine Pancreatic Insufficiency

128 studies on the registry are indexed under Exocrine Pancreatic Insufficiency; 27 are open to participants now.

This study's enrollment of 1,015 is above the median of 115 across 35 observational studies indexed under Exocrine Pancreatic Insufficiency.

Browse Exocrine Pancreatic Insufficiency studies →

Lead sponsor

Hospital Clinico Universitario de Santiago is the lead sponsor of 33 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,015 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • DrugPancreatic Enzyme

    Registry of pancreatic enzyme therapy prescribed to included patients

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What researchers measure

Primary outcomes

  1. Dose of oral pancreatic enzymes

    Dose required for symptoms relief and normalization of the nutritional status

    Time frame: Six months

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Study locations

1 site
  • Hospital Clinico Universitario de Santiago
    Santiago de Compostela, A Coruña 15706, Spain
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References and documents

Individual participant data

Plan to share: Yes — The data that support the findings of this study are available from the corresponding author upon reasonable request.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05450627
Lead sponsor
Hospital Clinico Universitario de Santiago
Collaborators
Instituto de Investigacion Sanitaria de Santiago de Compostela
Responsible party
J. Enrique Domínguez-Muñoz (Head of the Department of Gastroenterology, Hospital Clinico Universitario de Santiago) — Principal investigator
First posted
Jul 11, 2022
Start date
Jun 1, 2021
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Jun 22, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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