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Clinical Trials/NCT05450627
NCT05450627
Unknown
Not Applicable

Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies

Hospital Clinico Universitario de Santiago1 site in 1 country1,000 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Pancreatic Enzyme
Conditions
Exocrine Pancreatic Insufficiency
Sponsor
Hospital Clinico Universitario de Santiago
Enrollment
1000
Locations
1
Primary Endpoint
Dose of oral pancreatic enzymes
Last Updated
3 years ago

Overview

Brief Summary

A prospective, cross-sectional, observational study has been designed with the aim of the study is to evaluate the diagnosis and management of patients with pancreatic exocrine insufficiency secondary to different pancreatic diseases and conditions in clinical practice.

A registry has been develop to include patients older than 18 years diagnosed with pancreatic exocrine insufficiency, sho are willing to participate in the study and sign the informed consent.

Registry includes demographics, toxic habits,pharmacological therapies, underlying disease that causes pancreatic exocrine insufficiency.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

J. Enrique Domínguez-Muñoz

Head of the Department of Gastroenterology

Hospital Clinico Universitario de Santiago

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.

Arms & Interventions

Case

Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology

Intervention: Pancreatic Enzyme

Outcomes

Primary Outcomes

Dose of oral pancreatic enzymes

Time Frame: Six months

Dose required for symptoms relief and normalization of the nutritional status

Study Sites (1)

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