Registry of Pancreatic Exocrine Insufficiency.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Exocrine Pancreatic Insufficiency
• Intervention / Treatment: Drug: Pancreatic Enzyme

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: J. Enrique Dominguez-Munoz, Prof, MD, PhD; Phone Number: -34 981 951 364; Email: juan.enrique.dominguez.munoz@sergas.es

Study Locations

• Spain
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Recruiting
      • Hospital Clinico Universitario De Santiago
      • Contact: J. Enrique Dominguez-Munoz, MD, PhD; Phone Number: +34 981951364; Email: juan.enrique.dominguez.munoz@sergas.es
      • Contact: Xurxo Martínez-Seara; Phone Number: +34 981951364; Email: xurxoensayos@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology	Drug: Pancreatic Enzyme; Registry of pancreatic enzyme therapy prescribed to included patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose of oral pancreatic enzymes	Dose required for symptoms relief and normalization of the nutritional status	Six months

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Exocrine Pancreatic Insufficiency
• Other Study ID Numbers: PEI-01-2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No