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Fecal pancreatic elastase: a reproducible marker for severe exocrine pancreatic insufficiency

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Abstract

Background

In order to apply fecal pancreatic elastase for follow-up of exocrine pancreatic function in chronic pancreatitis and cystic fibrosis, we examined the sensitivity, specificity, and long-term variability of a new polyclonal antibody-based enzyme-linked immunosorbent assay (ELISA).

Methods

Patients with definite chronic pancreatitis (n = 23), probable or possible chronic pancreatitis (n = 14), autoimmune pancreatitis (n = 7), or acute pancreatitis (n = 11), and 51 healthy subjects and 11 healthy infants participated in this study. Pancreatic function was graded as normal (n = 3), mild (n = 18), moderate (n = 9), or severe (n = 18) exocrine insufficiency on the basis of secretin tests. Fecal pancreatic elastase was measured by a new ELISA.

Results

Fecal pancreatic elastase concentration in control subjects varied widely, with a median of 478 µg/g. The specificity of this test was 90.2% with a cutoff value of >200 µg/g. The sensitivities were 60.9% for detecting definite chronic pancreatitis, 76.5% for calcifying pancreatitis, 71.4% for autoimmune pancreatitis, and 7.1% for probable or possible chronic pancreatitis. The sensitivities were 16.7% for mild, 12.5% for moderate, and 72.2% for severe exocrine pancreatic insufficiency. Forty patients were reexamined after a median interval of 347 days. The fecal pancreatic elastase levels between the first and second tests were not significantly different. Two infants, 4.5 and 5 months old, had abnormally low values, but after a median of 304 days all infants showed normal levels (median, 444 µg/g).

Conclusions

Fecal pancreatic elastase is a reproducible marker for severe exocrine pancreatic insufficiency. This test is valuable for longitudinal follow-up of exocrine pancreatic function.

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Authors and Affiliations

  1. Department of Gastroenterology, Nagoya University Graduate School of Medicine, Nagoya, Japan

    Satoru Naruse, Hiroshi Ishiguro, Shigeru B.H. Ko, Toshiyuki Yoshikawa, Takeshi Yamamoto, Sachiko Futakuchi & Hidemi Goto

  2. Department of Human Nutrition, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan

    Hiroshi Ishiguro & Akiko Yamamoto

  3. Chubu Health Care Center, Nagoya, Japan

    Yukio Saito

  4. Nihon Schering K.K., Sakura, Japan

    Susumu Takahashi

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  1. Satoru Naruse
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Naruse, S., Ishiguro, H., Ko, S. et al. Fecal pancreatic elastase: a reproducible marker for severe exocrine pancreatic insufficiency. J Gastroenterol 41, 901–908 (2006). https://doi.org/10.1007/s00535-006-1884-0

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  • DOI: https://doi.org/10.1007/s00535-006-1884-0

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