BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency
Completed
- Conditions
- Exocrine Pancreatic Insufficiency
- Interventions
- Diagnostic Test: BÜHLMANN fPELA assay
- Registration Number
- NCT04548778
- Lead Sponsor
- Bühlmann Laboratories AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description no exocrine pancreatic insufficiency (no PEI) BÜHLMANN fPELA assay No evidence of PEI according to routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT). exocrine pancreatic insufficiency (PEI) BÜHLMANN fPELA assay Established diagnosis of PEI based on a routine clinical diagnostic work-up including a treat-to-diagnose approach using Pancreatic Enzyme Replacement Therapy (PERT).
- Primary Outcome Measures
Name Time Method Clinical Performance of BÜHLMANN fPELA assays in the diagnosis of PEI December 2021 Diagnostic sensitivity and specificity of BÜHLMANN fPELA assays
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsklinikum Halle (Saale)
🇩🇪Halle (Saale), Germany