NCT05450627

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

2.1 years

First QC Date

July 5, 2022

Last Update Submit

July 7, 2022

Conditions

Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Dose of oral pancreatic enzymes

    Dose required for symptoms relief and normalization of the nutritional status

    Six months

Study Arms (1)

Case

Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology

Drug: Pancreatic Enzyme

Interventions

Pancreatic EnzymeDRUG

Registry of pancreatic enzyme therapy prescribed to included patients

Case

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with pancreatic exocrine insufficiency of any etiology.

You may qualify if:

  • Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy.
  • Willingness to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

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

CONTACT

-34 981 951 364juan.enrique.dominguez.munoz@sergas.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Gastroenterology

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 11, 2022

Study Start

June 1, 2021

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations

ES(1)