To evaluate the feasibility the fecal Pancreas Elastase 1 Quick™ test (Quick test) for exocrine pancreatic function testing compared to standard fecal Pancreas Elastase 1 test with ELISA (ELISA test).
ID
Bron
Verkorte titel
Aandoening
Pancreatic exocrine insufficiency
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Accuracy of the Quick test compared with the standard fecal Pancreas Elastase 1 test with ELISA
Doel van het onderzoek
To evaluate the feasibility the fecal Pancreas Elastase 1 Quick™ test (Quick test) for exocrine pancreatic function testing compared to standard fecal Pancreas Elastase 1 test with ELISA (ELISA test).
Onderzoeksopzet
According to standard practice, the laboratory will perform the ELISA test (results available in 2-4 weeks). The coordinating investigator will collect and process the Quick test set and will report outcomes to the treating physician. The treating physician will report outcomes of the fecal elastase test to the patient when the results of the ELISA test are available.
Onderzoeksproduct en/of interventie
If a patient at the outpatient clinic has an indication for exocrine pancreatic function testing, the treating physician will request standard fecal elastase test according to standard practice. In addition, patients will be asked for informed consent to participate in the study.
If a patient is willing to participate in the study, he will also receive a Quick Test set with an information brochure from the treating physician. The patient will be instructed to perform the Quick test from the same stool sample that will be used for the ELISA test.
Publiek
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Wetenschappelijk
Academic Medical Center
Meibergdreef 9, C2-310
S. Lekkerkerker
Amsterdam 1105 AZ
The Netherlands
+31-205662061
s.j.lekkerkerker@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
‐ Patients with an indication for exocrine pancreatic function testing
‐ Verbal informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
‐ <18 years old
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5196 |
NTR-old | NTR5344 |
Ander register | METC AMC : W15_194 |