Systematic reviews and meta-analyses
Diagnostic Performance of Measurement of Fecal Elastase-1 in Detection of Exocrine Pancreatic Insufficiency: Systematic Review and Meta-analysis

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Background & Aims

Tests to quantify fecal levels of chymotrypsin like elastase family member 3 (CELA3 or elastase-1) in feces are widely used to identify patients with exocrine pancreatic insufficiency (EPI). However, the diagnostic accuracy of this test, an ELISA, is not clear. We performed a systematic review and meta-analysis to determine the accuracy of measurement of fecal elastase-1 in detection of EPI.

Methods

We searched PubMed, Embase, and reference lists for articles through November 2016 describing studies that compared fecal level of elastase-1 with results from a reference standard, direct method (secretin stimulation test), or indirect method (measurement of fecal fat) for detection of EPI. Sensitivity and specificity values were pooled statistically using bivariate diagnostic meta–analysis.

Results

We included total of 428 cases of EPI and 673 individuals without EPI (controls), from 14 studies, in the meta-analysis. The assay for elastase-1, compared to secretin stimulation test, identified patients with pancreatic insufficiency with a pooled sensitivity value of 0.77 (95% CI, 0.58–0.89) and specificity value of 0.88 (95% CI, 0.78–0.93). In an analysis of 345 cases of EPI and 312 controls, from 6 studies, the fecal elastase-1 assay identified patients with EPI with a pooled sensitivity value of 0.96 (95% CI, 0.79–0.99) and specificity value of 0.88 (95% CI, 0.59–0.97), compared to quantitative fecal fat estimation. In patients with low pre–test probability of EPI (5%), the fecal elastase-1 assay would have a false-negative rate of 1.1% and a false-positive rate of 11%, indicating a high yield in ruling out EPI but not in detection of EPI. In contrast, in patients with high pre-test probability of EPI (40%), approximately 10% of patients with EPI would be missed (false negatives).

Conclusions

In a systematic review and meta-analysis of studies that compared fecal level of elastase-1 for detection of EPI, we found that normal level of elastase-1 (above 200 mcg/g) can rule out EPI in patients with a low probability of this disorder (such as those with irritable bowel syndrome with diarrhea). However, in these patients, an abnormal level of elastase-1 (below 200 mcg/g) has a high false-positive rate.

Section snippets

Search Strategy

We searched PubMed and Embase from inception through November 2016 for relevant studies using a combination of MeSH terms and keywords according to PRISMA guidelines.22 The search terms were (Pancreatic elastase[tiab] OR fecal elastase[tiab] OR faecal elastase[tiab] OR pancreatic function tests[mesh:noexp]) AND (exocrine pancreatic insufficiency [mesh: noexp] OR pancreatic insufficiency [tiab]). We did not use any search restrictions. Two authors (R.R.V. and S.S.) independently screened studies

Results of the Search

We identified a total of 616 studies (Figure 1), of which, only 20 studies (19 papers and 1 abstract) that were published fulfilled the inclusion criteria and were included in the review (Tables 1 and 2). All 20 studies were observational. A total of 8 different countries were represented. Nine studies evaluated adults only, 10 studies evaluated both adults and children, and 1 study evaluated children only. In FE-1 versus secretin stimulation test analysis of 14 studies, data on 1101 patients

Discussion

This is the first study in the English literature to perform a systematic review and meta-analysis of the diagnostic utility of FE-1 in EPI. Based on our review, the pooled sensitivity and specificity of FE-1 versus secretin stimulation test when all 16 studies were included was 0.77 (95% CI, 0.58–0.89) and 0.88 (95% CI, 0.78–0.93), respectively, and diagnostic accuracy was 23 (95% CI, 6–84). This diagnostic accuracy was maintained when several sensitivity analyses were performed, as shown in

References (41)

  • F. Erchinger et al.

    Quantification of pancreatic function using a clinically feasible short endoscopic secretin test

    Pancreas

    (2013)
  • T. Stevens et al.

    Update on endoscopic pancreatic function testing

    World J Gastroenterol

    (2011)
  • J. Toouli et al.

    Management of pancreatic exocrine insufficiency: Australasian Pancreatic Club recommendations

    Med J Aust

    (2010)
  • J.E. Dominguez-Munoz et al.

    Fecal elastase test: evaluation of a new noninvasive pancreatic function test

    Am J Gastroenterol

    (1995)
  • C. Loser et al.

    Faecal elastase 1: a novel, highly sensitive, and specific tubeless pancreatic function test

    Gut

    (1996)
  • J. Stein et al.

    Immunoreactive elastase I: clinical evaluation of a new noninvasive test of pancreatic function

    Clin Chem

    (1996)
  • K.D. Fine et al.

    A new method of quantitative fecal fat microscopy and its correlation with chemically measured fecal fat output

    Am J Clin Pathol

    (2000)
  • D. Rothenbacher et al.

    Prevalence and determinants of exocrine pancreatic insufficiency among older adults: results of a population-based study

    Scand J Gastroenterol

    (2005)
  • M. Vujasinovic et al.

    Exocrine pancreatic insufficiency, MRI of the pancreas and serum nutritional markers in patients with coeliac disease

    Postgrad Med J

    (2015)
  • R. Mattar et al.

    Comparison of fecal elastase 1 for exocrine pancreatic insufficiency evaluation between ex-alcoholics and chronic pancreatitis patients

    Arq Gastroenterol

    (2014)
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    Conflicts of interest The authors disclose no conflicts.

    Funding Aylin Tansel is supported by the National Institutes of Health (grant T-32 5T32DK083266-07). This work is funded in part by the Texas Digestive Disease Center (National Institutes of Health grant DK58338). Dr. El-Serag is also supported by the National Institute of Diabetes and Digestive and Kidney Diseases (K24-04-107).

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