Evidence map›Paper›PMID 29374614›Full record

SynthesisClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2018

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

Rohini R Vanga, Aylin Tansel, Saad Sidiq, Hashem B El-Serag, Mohamed O Othman

Registry-linked trialAbstract readEvaluation StudyMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05480241 (Impact of Exocrine Pancreatic Insufficiency Associated With Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy on Gut Microbiota, Immunological Changes and Quality of Life), which is not on this map. Cited by 85 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 9 pooled it
18.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05480241 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Impact of Exocrine Pancreatic Insufficiency Associated With Acute Pancreatitis and Pancreatic Enzyme Replacement Therapy on Gut Microbiota, Immunological Changes and Quality of Life

TypeinterventionalSponsorUnidade Local de Saúde de Coimbra, EPERan2022 to 2024Enrolled84ConditionsAcute Pancreatitis, Exocrine Pancreatic Insufficiency, Gut Microbiota, ImmunologyArmsPancreatic Enzyme Replacement Therapy, Placebo
3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 9 syntheses or guidelines pooled it, 211 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Timing of pancreatic enzyme replacement therapy (PERT) in cystic fibrosis.The Cochrane database of systematic reviews · 2021
    Pooled it
  9. Pooled it
  10. [When the intestine swallows the pounds].Innere Medizin (Heidelberg, Germany) · 2026
    Article
  11. Unique causes of exocrine pancreatic insufficiency: When to consider pancreatic enzyme supplementation: A narrative review.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2026
    Review
  12. Article
  13. Review
  14. High Frequency of Pancreatic Exocrine Insufficiency Among Patients with Abdominal Pain, Bloating, and Malodorous Flatus: Hidden Pancreatic InsufficiencyThe Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026
    Article
  15. Article
  16. Clinical Practice Update on the Evaluation, Diagnosis, and Management of Pancreatic Exocrine Insufficiency: Expert Review.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026
    Review
  17. Article
  18. Article
  19. Article
  20. Review

25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Rohini R VangaSection of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas.
Aylin TanselSection of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas.
Saad SidiqUniversity of Houston, Houston, Texas.
Hashem B El-SeragSection of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas; Center for Innovations in Quality, Effectiveness, and Safety, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas; Section of Gastroenterology and Hepatology, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas.
Mohamed O OthmanSection of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas. Electronic address: Mohamed.othman@bcm.edu.
Baylor College of Medicine · USMichael E. DeBakey VA Medical Center · USUniversity of Houston · US

Funding

Tissue Analysis & Molecular Imaging CoreP30DK056338 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Hashem B El-Serag · 2001 to 2026
$28.3M
Research Training in GastroenterologyT32DK083266 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Hashem B El-Serag, FASIHA KANWAL · 2010 to 2026
$2.3M
Epidemiology and Outcomes of Digestive and Liver Diseases: A Mentoring ProgramK24DK078154 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI EL-SERAG, HASHEM B · 2007 to 2016
$1.1M
NIDDK NIH HHS K24 DK078154NIDDK NIH HHS P30 DK056338NIDDK NIH HHS T32 DK083266
6 · The paper itself

Abstract

BACKGROUND &

aimsTests 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.

methodsWe 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.

resultsWe 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).

conclusionsIn 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.

Indexed as

AdolescentAdultAgedAged, 80 and overChildChild, PreschoolDiagnostic Tests, RoutineExocrine Pancreatic InsufficiencyFecesFemaleHumansInfantInfant, NewbornMaleMiddle AgedPancreatic ElastasePancreatic ElastaseEnzymeExocrine Pancreatic InsufficiencyPancreasProteolysisSteatorrhea

Identifiers

PMID29374614
PMCPMC6402774
OpenAlexW2785648231

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.