BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

BÜHLMANN Laboratories

Status: Completed

Conditions: Exocrine Pancreatic Insufficiency

Treatments: Diagnostic Test: BÜHLMANN fPELA assay

Study type: Observational

Funder types: Industry

Identifiers

NCT04548778

fPELA_ClinPerform2020

Details and patient eligibility

About

The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).

This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site.

Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suspected exocrine pancreatic insufficiency
• at least 18 years of age.

Exclusion criteria

• diarrhea (stool water content ≥ 75%) at the time of sample collection

Trial design

201 participants in 2 patient groups

exocrine pancreatic insufficiency (PEI)

Description:

Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).

Treatment:

Diagnostic Test: BÜHLMANN fPELA assay

no exocrine pancreatic insufficiency (no PEI)

Description:

No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).

Treatment:

Diagnostic Test: BÜHLMANN fPELA assay