Registry of Pancreatic Exocrine Insufficiency.

Sponsor

Hospital Clinico Universitario de Santiago (Other)

Overall Status

Recruiting

CT.gov ID

NCT05450627

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

32.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exocrine Pancreatic Insufficiency	Drug: Pancreatic Enzyme

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Dose of oral pancreatic enzymes [Six months]
Dose required for symptoms relief and normalization of the nutritional status

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinico Universitario de Santiago	Santiago de Compostela	A Coruña	Spain	15706

Sponsors and Collaborators

Hospital Clinico Universitario de Santiago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

J. Enrique Domínguez-Muñoz, Head of the Department of Gastroenterology, Hospital Clinico Universitario de Santiago

ClinicalTrials.gov Identifier:

NCT05450627

Other Study ID Numbers:

PEI-01-2021

First Posted:

Jul 11, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Exocrine Pancreatic Insufficiency

Study Results

No Results Posted as of Jul 11, 2022