BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

NCT04548778 | Completed

• 1 other identifier: fPELA_ClinPerform2020
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI

  Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays

  December 2021

Study Arms (2)

exocrine pancreatic insufficiency (PEI)

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

Diagnostic Test: BÜHLMANN fPELA assay

no exocrine pancreatic insufficiency (no PEI)

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

Diagnostic Test: BÜHLMANN fPELA assay

Interventions

BÜHLMANN fPELA assay DIAGNOSTIC_TEST

BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

exocrine pancreatic insufficiency (PEI); no exocrine pancreatic insufficiency (no PEI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. Following patient groups show an increased risk for developing an exocrine insufficiency: chronic pancreatitis, cystic fibrosis, diabetes, pancreatic resection. Eligible study subjects provide one stool sample which is forwarded to the study site within three days.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bühlmann Laboratories AG: lead

Study Sites (1)

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Jonas Rosendahl, MD

  Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 16, 2020
• Study Start: November 1, 2020
• Primary Completion: September 21, 2024
• Study Completion: September 21, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-08

Locations

DE (1)