Use of fecal elastase-1 to classify pancreatic status in patients with cystic fibrosis

J Pediatr. 2004 Sep;145(3):322-6. doi: 10.1016/j.jpeds.2004.04.049.


Objective: To test the hypothesis that some patients with cystic fibrosis (CF) are misclassified as pancreatic insufficient, using fecal elastase-1 (FE-1) to define pancreatic status.

Study design: Subjects with CF at 33 CF centers filled out questionnaires and submitted a stool specimen that was analyzed for FE-1. Subjects taking pancreatic enzyme supplements (PES) were asked to discontinue them and perform a 3-day fecal fat balance study if their FE-1 was >200 microg/g stool and they had never had pancreatitis.

Results: The median value for FE-1 in 1215 subjects was 0 microg/g stool (range, 0-867). There was a significant difference between patients who had been prescribed PES (n=1131) and those who had FE-1 <200 microg/g stool (n=1074; P<.0001). Sixty-seven subjects met criteria for discontinuation of PES. The mean coefficient of fat absorption for these subjects was 96.1%.

Conclusions: FE-1 is an accurate, easily obtained screening test to classify pancreatic status in patients with CF. This information is important for prognostication, treatment, and to avoid misclassification in clinical research. Measurement of FE-1 should become a standard of care for patients with CF.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Child, Preschool
  • Cystic Fibrosis / complications*
  • Cystic Fibrosis Transmembrane Conductance Regulator / genetics
  • Exocrine Pancreatic Insufficiency / classification
  • Exocrine Pancreatic Insufficiency / enzymology*
  • Exocrine Pancreatic Insufficiency / etiology
  • Feces / enzymology*
  • Female
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Mutation
  • Pancreatic Elastase / isolation & purification
  • Pancreatic Elastase / metabolism*
  • Registries


  • CFTR protein, human
  • Cystic Fibrosis Transmembrane Conductance Regulator
  • Pancreatic Elastase