Evidence map›Paper›PMID 40569793›Full record

SynthesisUnited European gastroenterology journal2025

Diagnostic Accuracy of Fecal Elastase-1 Test for Pancreatic Exocrine Insufficiency: A Systematic Review and Meta-Analysis.

Daniel de la Iglesia, Belén Agudo-Castillo, Marco Galego-Fernández, Alberto Rama-Fernández, J Enrique Domínguez-Muñoz

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in United European gastroenterology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. 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
  3. Article
  4. Article
  5. Pancreatic exocrine insufficiency.EClinicalMedicine · 2026
    Review
  6. Article
  7. Review
  8. Idiopathic chronic pancreatitis: clinical highlights.Therapeutic advances in gastroenterology · 2026
    Review
  9. Article
  10. Article
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.

Daniel de la IglesiaDepartment of Gastroenterology and Hepatology, Puerta de Hierro University Hospital, Health Research Institute of Puerta de Hierro-Segovia de Arana, Majadahonda, Spain.ORCID https://orcid.org/0000-0002-1826-2282
Belén Agudo-CastilloDepartment of Gastroenterology and Hepatology, Puerta de Hierro University Hospital, Health Research Institute of Puerta de Hierro-Segovia de Arana, Majadahonda, Spain.ORCID https://orcid.org/0000-0003-2504-351X
Marco Galego-FernándezDepartment of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.ORCID https://orcid.org/0000-0002-8734-5719
Alberto Rama-FernándezDepartment of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.
J Enrique Domínguez-MuñozDepartment of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPancreatic exocrine insufficiency (PEI) results from a reduction in pancreatic secretion of enzymes, leading to malabsorption of nutrients, intestinal symptoms, nutritional deficiencies and related comorbidities. The diagnosis of pancreatic exocrine insufficiency should be based on digestive tests, mainly the coefficient of fat absorption (CFA), based on the quantification of 72 h fecal fat excretion (FFE). However, this test is rarely performed in clinical practice. Fecal elastase-1 (FE-1) is a simple and widely used alternative. This meta-analysis evaluates the diagnostic accuracy of fecal elastase-1 for the diagnosis of PEI diagnosed by CFA or 72h-FFE.

methodsA systematic search of databases was performed to identify studies evaluating fecal elastase-1 and CFA/FFE for the diagnosis of pancreatic exocrine insufficiency. Inclusion criteria required original studies with data on sensitivity, specificity and other diagnostic metrics. Two independent reviewers performed data extraction and quality assessment using the QUADAS-2 tool. Pooled sensitivity, specificity, likelihood ratios and diagnostic odds ratio (DOR) were calculated and heterogeneity was assessed using I-squared tests.

resultsThirteen studies with 888 patients were included. Fecal elastase-1 at a cut-off of 200 μg/g showed a pooled sensitivity and specificity of 0.94 and 0.69, respectively, with a DOR of 35.27. Lowering the cut-off to 100 μg/g improved specificity to 0.82 but decreased sensitivity to 0.88. Subgroup analyses showed different diagnostic performance in different clinical contexts, with higher sensitivity in cystic fibrosis (0.98) and higher specificity in chronic pancreatitis (0.81). The positive and negative predictive values are limited in situations with low and high probability of pancreatic exocrine insufficiency, respectively.

conclusionsFecal elastase-1 is a sensitive and moderately specific diagnostic tool for pancreatic exocrine insufficiency and is suitable for initial screening in high-risk populations. However, its moderate specificity requires careful interpretation in lower risk settings.

Indexed as

Exocrine Pancreatic InsufficiencyFecesPancreatic ElastaseBiomarkersHumansPancreatic Function TestsSensitivity and SpecificityBiomarkersPancreatic Elastasechronic pancreatitiscoefficient of fat absorptioncystic fibrosisdiagnostic accuracyfat absorptionfecal elastasefecal fat excretionmeta‐analysispancreatic exocrine insufficiencysystematic review

Identifiers

PMID40569793
PMCPMC12529004

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.