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. 2017 Apr 21;4(4):CD012010.
doi: 10.1002/14651858.CD012010.pub2.

Serum amylase and lipase and urinary trypsinogen and amylase for diagnosis of acute pancreatitis

Gianluca Rompianesi  1 , Angus Hann  2 , Oluyemi Komolafe  3 , Stephen P Pereira  4 , Brian R Davidson  5 , Kurinchi Selvan Gurusamy  5
Affiliations

Serum amylase and lipase and urinary trypsinogen and amylase for diagnosis of acute pancreatitis

Gianluca Rompianesi et al. Cochrane Database Syst Rev. .

Abstract

Background: The treatment of people with acute abdominal pain differs if they have acute pancreatitis. It is important to know the diagnostic accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase for the diagnosis of acute pancreatitis, so that an informed decision can be made as to whether the person with abdominal pain has acute pancreatitis. There is currently no Cochrane review of the diagnostic test accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase for the diagnosis of acute pancreatitis.

Objectives: To compare the diagnostic accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase, either alone or in combination, in the diagnosis of acute pancreatitis in people with acute onset of a persistent, severe epigastric pain or diffuse abdominal pain.

Search methods: We searched MEDLINE, Embase, Science Citation Index Expanded, National Institute for Health Research (NIHR HTA and DARE), and other databases until March 2017. We searched the references of the included studies to identify additional studies. We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively. We also performed a 'related search' and 'citing reference' search in MEDLINE and Embase.

Selection criteria: We included all studies that evaluated the diagnostic test accuracy of serum amylase, serum lipase, urinary trypsinogen-2, and urinary amylase for the diagnosis of acute pancreatitis. We excluded case-control studies because these studies are prone to bias. We accepted any of the following reference standards: biopsy, consensus conference definition, radiological features of acute pancreatitis, diagnosis of acute pancreatitis during laparotomy or autopsy, and organ failure. At least two review authors independently searched and screened the references located by the search to identify relevant studies.

Data collection and analysis: Two review authors independently extracted data from the included studies. The thresholds used for the diagnosis of acute pancreatitis varied in the trials, resulting in sparse data for each index test. Because of sparse data, we used -2 log likelihood values to determine which model to use for meta-analysis. We calculated and reported the sensitivity, specificity, post-test probability of a positive and negative index test along with 95% confidence interval (CI) for each cutoff, but have reported only the results of the recommended cutoff of three times normal for serum amylase and serum lipase, and the manufacturer-recommended cutoff of 50 mg/mL for urinary trypsinogen-2 in the abstract.

Main results: Ten studies including 5056 participants met the inclusion criteria for this review and assessed the diagnostic accuracy of the index tests in people presenting to the emergency department with acute abdominal pain. The risk of bias was unclear or high for all of the included studies. The study that contributed approximately two-thirds of the participants included in this review was excluded from the results of the analysis presented below due to major concerns about the participants included in the study. We have presented only the results where at least two studies were included in the analysis.Serum amylase, serum lipase, and urinary trypsinogen-2 at the standard threshold levels of more than three times normal for serum amylase and serum lipase, and a threshold of 50 ng/mL for urinary trypsinogen-2 appear to have similar sensitivities (0.72 (95% CI 0.59 to 0.82); 0.79 (95% CI 0.54 to 0.92); and 0.72 (95% CI 0.56 to 0.84), respectively) and specificities (0.93 (95% CI 0.66 to 0.99); 0.89 (95% CI 0.46 to 0.99); and 0.90 (95% CI 0.85 to 0.93), respectively). At the median prevalence of 22.6% of acute pancreatitis in the studies, out of 100 people with positive test, serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL), 74 (95% CI 33 to 94); 68 (95% CI 21 to 94); and 67 (95% CI 57 to 76) people have acute pancreatitis, respectively; out of 100 people with negative test, serum amylase (more than three times normal), serum lipase (more than three times normal), and urinary trypsinogen (more than 50 ng/mL), 8 (95% CI 5 to 12); 7 (95% CI 3 to 15); and 8 (95% CI 5 to 13) people have acute pancreatitis, respectively. We were not able to compare these tests formally because of sparse data.

Authors' conclusions: As about a quarter of people with acute pancreatitis fail to be diagnosed as having acute pancreatitis with the evaluated tests, one should have a low threshold to admit the patient and treat them for acute pancreatitis if the symptoms are suggestive of acute pancreatitis, even if these tests are normal. About 1 in 10 patients without acute pancreatitis may be wrongly diagnosed as having acute pancreatitis with these tests, therefore it is important to consider other conditions that require urgent surgical intervention, such as perforated viscus, even if these tests are abnormal.The diagnostic performance of these tests decreases even further with the progression of time, and one should have an even lower threshold to perform additional investigations if the symptoms are suggestive of acute pancreatitis.

PubMed Disclaimer

Conflict of interest statement

This report is independent research funded by the National Institute for Health Research (NIHR Cochrane Programme Grants, 13/89/03 ‐ Evidence‐based diagnosis and management of upper digestive, hepato‐biliary, and pancreatic disorders). The views expressed in this publication are those of the author(s) and not necessarily those of the National Health Service, the NIHR, or the Department of Health.

GR: none known.

AH: none known.

OK: none known.

SPP: none known.

BRD: none known.

KSG: none known.

Figures

1
1
Clinical pathway. Footnotes:

  1. Acute pancreatitis is usually confirmed by consensus criteria (Banks 2013).

  2. Irrespective of the CT scan findings and presence or absence of necrosis, patients with organ failure will require organ support and will receive a CT scan.

  3. CT scan may also be performed in people without organ failure if there is clinical deterioration (not amounting to organ failure) or in some centres based on an elevated CRP.

  4. Necrotising pancreatitis is usually confirmed by the findings on the CT scan and by histopathological examination of the biopsy obtained during necrosectomy if early necrosectomy is performed.

  5. Infected necrotising pancreatitis is usually confirmed by the findings on the CT scan and by microbiological examination of fluid aspirated under radiological guidance or from the tissue biopsy obtained during necrosectomy if early necrosectomy is performed.

  6. Organ failure is diagnosed on the basis of clinical examination and blood tests (urea, creatinine, blood pressure, pulse rate, respiratory rate, arterial blood gas analysis).

Abbreviations: CRP: C‐reactive protein
 CT: computed tomography
 EUS: endoscopic ultrasound
 MRCP: magnetic resonance cholangiopancreatography
2
2
Study flow diagram.
3
3
Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study.
4
4
Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies.
5
5
Forest plot of serum amylase, serum lipase, and urinary trypsinogen at different thresholds. There was reasonable overlap of 95% confidence intervals except specificity for serum amylase > 3 times normal, sensitivity and specificity of serum lipase > 3 times normal, and specificity of urinary trypsinogen‐2.
6
6
Summary estimates and 95% confidence region (ellipses) of the three main meta‐analyses showing similar diagnostic test accuracies. No confidence regions could be computed for serum amylase due to small numbers of studies.
See this image and copyright information in PMC

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Dalgat 1986 {published data only}
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Frost 1978 {published data only}
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Haffter 1983 {published data only}
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Hathaway 1983 {published data only}
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Hofmeyr 2014 {published data only}
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Horanyi 1984 {published data only}
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Hostein 1976 {published data only}
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Houry 1989 {published data only}
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References to studies awaiting assessment

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Cherry 1953 {published data only}
    1. Cherry JW. Diagnosis of acute pancreatitis. Proc Clin Honolulu 1953;19(5):73‐7.
Coppola 1954 {published data only}
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References to other published versions of this review

Gurusamy 2015
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