Registry of Pancreatic Exocrine Insufficiency.

NCT ID: NCT05450627

Last Updated: 2022-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Exocrine Pancreatic Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology

Pancreatic Enzyme

Intervention Type DRUG

Registry of pancreatic enzyme therapy prescribed to included patients

Interventions

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Pancreatic Enzyme

Registry of pancreatic enzyme therapy prescribed to included patients

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinico Universitario de Santiago

OTHER

Sponsor Role lead

Responsible Party

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J. Enrique Domínguez-Muñoz

Head of the Department of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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

Role: CONTACT

-34 981 951 364

Facility Contacts

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J. Enrique Dominguez-Munoz, MD, PhD

Role: primary

+34 981951364

Xurxo Martínez-Seara

Role: backup

+34 981951364

Other Identifiers

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PEI-01-2021

Identifier Type: -

Identifier Source: org_study_id

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