Potential for Screening for Pancreatic Exocrine Insufficiency Using the Fecal Elastase-1 Test
The early diagnosis of pancreatic exocrine insufficiency (PEI) is hindered because many of the functional diagnostic techniques used are expensive and require specialized facilities, which prevent their widespread availability. We have reviewed current evidence in order to compare the utility of these functional diagnostic techniques with the fecal elastase-1 (FE-1) test in the following three scenarios: screening for PEI in patients presenting with symptoms suggestive of pancreatic disease, such as abdominal pain or diarrhea; determining the presence of PEI in patients with an established diagnosis of pancreatic disease, such as chronic pancreatitis or cystic fibrosis; determining exocrine status in disorders not commonly tested for PEI, but which have a known association with this disorder. Evidence suggests the FE-1 test is reliable for the evaluation of pancreatic function in many pancreatic and non-pancreatic disorders. It is non-invasive, is less time-consuming, and is unaffected by pancreatic enzyme replacement therapy. Although it cannot be considered the gold-standard method for the functional diagnosis of PEI, the advantages of the FE-1 test make it a very appropriate test for screening patients who may be at risk of this disorder.
KeywordsFecal elastase-1 Pancreatic exocrine insufficiency Chronic pancreatitis Diabetes mellitus Malnutrition
Editorial assistance was provided to authors during the drafting of this manuscript by Martin Wallace PhD (Alpharmaxim Healthcare Communications). Funding for this assistance was provided by Mylan.
Compliance with ethical standards
Conflicts of interest
Prof. Domínguez-Muñoz has participated in consulting and speaking activities for Abbott Laboratories Ltd., Mylan N.V., and Allergan plc. Prof. Hardt has participated in consulting and speaking activities for Abbott Laboratories Ltd., AbbVie Ltd., and Shire plc. Prof. Lerch has participated in consulting and speaking activities for AbbVie Ltd., Abbott Laboratories Ltd., Dr. Falk Pharma GmbH, AstraZeneca plc., Nordmark Arzneimittel GmbH & Co. KG, Centogene AG, and KMG. Prof. Löhr has participated in consulting and speaking activities for Abbott Laboratories Ltd., and consultancy activities for Nordmark Arzneimittel GmbH & Co. KG.
- 13.Gubergrits N, Malecka-Panas E, Lehman GA, et al. A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery. Aliment Pharmacol Ther. 2011;33:1152–1161.CrossRefPubMedGoogle Scholar
- 16.Seiler CM, Izbicki J, Varga-Szabó L, et al. Randomised clinical trial: a 1-week, double-blind, placebo-controlled study of pancreatin 25 000 Ph. Eur. minimicrospheres (Creon 25000 MMS) for pancreatic exocrine insufficiency after pancreatic surgery, with a 1-year open-label extension. Aliment Pharmacol Ther. 2013;37:691–702.CrossRefPubMedPubMedCentralGoogle Scholar
- 30.Hardt PD, Hauenschild A, Nalop J, et al. The commercially available ELISA for pancreatic elastase 1 based on polyclonal antibodies does measure an as yet unknown antigen different from purified elastase 1. Binding studies and clinical use in patients with exocrine pancreatic insufficiency. Z Gastroenterol. 2003;41:903–906.CrossRefPubMedGoogle Scholar
- 58.Hoffmeister A, Mayerle J, Beglinger C, et al. English language version of the S3-consensus guidelines on chronic pancreatitis: definition, aetiology, diagnostic examinations, medical, endoscopic and surgical management of chronic pancreatitis. Z Gastroenterol. 2015;53:1447–1495.CrossRefPubMedGoogle Scholar