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Clinical Efficacy of Serum Lipase Subtype Analy- Sis for the Differential Diagnosis of Pancreatic and Non-Pancreatic Lipase Elevation

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Clinical Efficacy of Serum Lipase Subtype Analy- Sis for the Differential Diagnosis of Pancreatic and Non-Pancreatic Lipase Elevation ORIGINAL ARTICLE Korean J Intern Med 2016;31:660-668 http://dx.doi.org/10.3904/kjim.2015.007 Clinical efficacy of serum lipase subtype analy- sis for the differential diagnosis of pancreatic and non-pancreatic lipase elevation Chang Seok Bang*, Jin Bong Kim*, Sang Hyun Park, Gwang Ho Baik, Ki Tae Su, Jai Hoon Yoon, Yeon Soo Kim, and Dong Joon Kim Department of Internal Medicine, Background/Aims: Non-pancreatic elevations of serum lipase have been reported, Hallym University College of and differential diagnosis is necessary for clinical practice. This study aimed to Medicine, Chuncheon, Korea evaluate the clinical efficacy of serum lipase subtype analysis for the differential diagnosis of pancreatic and non-pancreatic lipase elevation. Methods: Patients who were referred for the serum lipase elevation were prospec- tively enrolled. Clinical findings and serum lipase subtypes were analyzed and compared by dividing the patients into pancreatitis and non-pancreatitis groups. Results: A total of 34 patients (12 pancreatitis vs. 22 non-pancreatitis cases) were enrolled. In univariate analysis, the fraction of pancreatic lipase (FPL) in the total amount of serum lipase subtypes was statistically higher in patients with pancre- atitis ([median, 0.004; interquartile range [IQR], 0.003 to 0.011] vs. [median, 0.002; IQR, 0.001 to 0.004], p = 0.04). Based on receiver operating characteristic curve Received : January 11, 2015 Revised : May 23, 2015 analysis for the prediction of acute pancreatitis, FPL was the most valuable pre- Accepted : June 9, 2015 dictor (area under the receiver-operating characteristic curve [AUROC], 0.72; 95% confidence interval [CI], 0.54 to 0.86; sensitivity, 83.3%; specificity, 63.6%; positive Correspondence to Jin Bong Kim, M.D. predictive value, 55.6%; negative predictive value, 97.5%). In multivariate analysis, Department of Internal Medicine, a cut-off value higher than 0.0027 for the FPL was associated with acute pancre- Hallym University College of atitis (odds ratio, 8.3; 95% CI, 1.3 to 51.7; p = 0.02). Medicine, 77 Sakju-ro, Chuncheon Conclusions: The results did not support that serum lipase subtype analysis 24253, Korea Tel: +82-33-240-5811 could replace standard lipase measurement for the diagnosis of acute pancreati- Fax: +82-33-241-8064 tis. However, the test demonstrated adequate sensitivity for use in triage or as an E-mail: [email protected] add-on test for serum lipase elevation. *These authors contributed equal- ly to this work. Keywords: Lipase; Lipase subtypes; Pancreatitis INTRODUCTION hemorrhage and even idiopathic cases have been report- ed, and differential diagnosis is needed for clinical prac- Elevation of serum lipase activity is included in the diag- tice [2-5]. Because the interpretation of elevated serum nostic criteria for acute pancreatitis [1]. However, non-pan- lipase concentrations is complex, cross-sectional imag- creatic elevations of serum lipase levels, such as increases ing studies, including computed tomography (CT) or due to renal insufficiency, bowel obstructions, diabetic magnetic resonance imaging, are usually recommended. ketoacidosis, inflammatory bowel disease, and intracranial However, these modalities have the limitations of radia- Copyright © 2016 The Korean Association of Internal Medicine pISSN 1226-3303 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/ eISSN 2005-6648 by-nc/3.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited. http://www.kjim.org Bang CS, et al. Serum lipase subtype analysis tion exposure or high expense. Clinical findings were recorded for the following vari- Pancreatic lipase, also known as pancreatic triacyl- ables: age, sex, alcohol use, smoking history, body mass glycerol lipase, is secreted into the duodenum, and the index (BMI), presence of intracranial hemorrhage, and serum level of this enzyme is low in patients without laboratory results, including serum amylase, lipase, as- pancreatic diseases. However, under conditions of pan- partate aminotransferase (AST), alanine aminotransfer- creatic injury, pancreatic autolysis induces elevation of ase (ALT), alkaline phosphatase (ALP), gamma glutamyl the serum pancreatic lipase level. In the measurement transpeptidase (GGT), and C-reactive protein (CRP). Se- of serum lipase levels, the triglyceride lipase gene sub- rum amylase and lipase levels were measured by enzy- family, including lipoprotein lipase, hepatic lipase, and matic colorimetric assay (Cobas 8000 C702 Chemistry endothelial lipase, is also measured [6]. Thus, measure- autoanalyzer, Roche-Hitachi Corp., Basel, Switzerland), ment of only serum pancreatic lipase concentrations which is a form of spectrophotometric assay. Among is more specific and more rational for the differential the serial laboratory outcomes, values at the time of the diagnosis of serum lipase elevation. This study aimed highest lipase level were selected and recorded. All of to evaluate the clinical efficacy of serum lipase subtype the laboratory variables were measured and reported by analysis for the differential diagnosis of pancreatic and the Laboratory Medicine Department of Hallym Uni- non-pancreatic serum lipase elevation. versity Chuncheon Sacred Heart Hospital (2013-82). Enzyme-linked immunosorbent assay METHODS Blood samples obtained from the enrolled patients were allowed to clot for 30 minutes at room temperature. Af- Ethics statement ter centrifugation, serum was collected and stored at This study was conducted according to the principles –80°C. The activity of serum lipase subtypes was mea- expressed in the Declaration of Helsinki. Voluntary sured using an enzyme-linked immunosorbent assay participation was requested, and written informed con- (ELISA) analysis kit (Cloud-Clone Corp., Houston, TX, sent was obtained from each participant. This study was USA) for pancreatic lipase, endothelial lipase, lipopro- approved by the Institutional Review Board of Hallym tein lipase, and hepatic lipase, according to the manu- University Chuncheon Sacred Heart Hospital. facturer’s protocol. The minimum detectable doses the lipase subtypes were typically less than 0.239 ng/mL for Study design pancreatic lipase, less than 27 pg/mL for endothelial li- This study was conducted at Hallym University Chun- pase, less than 0.247 ng/mL for lipoprotein lipase, and cheon Sacred Heart Hospital, a teaching hospital in the less than 33 pg/mL for hepatic lipase. The coefficient of Korea. From July 2012 through February 2014, consecu- variation (CV) was calculated using the following equa- tive patients who were referred to the pancreatobiliary tion, and the values of the intra- and interassay CVs department for serum lipase elevation were prospective- were as follows; CV (%) = standard deviation / mean × ly enrolled. Clinical findings and serum lipase subtypes 100; intra-assay, CV < 10%; inter-assay, CV < 12%. A bio- (pancreatic, endothelial, lipoprotein, and hepatic lipase) chemical analyzer assessed the lipase subtype levels in were analyzed and compared after division into pancre- the serum. Absorbance (A) was detected at 450 nm. The atitis and non-pancreatitis groups. content of each sample was estimated using a standard The diagnosis of acute pancreatitis was made accord- curve. ing to the revised definition of Atlanta 2012 —two of the following three features: (1) acute onset of persistent, Statistical analysis severe, epigastric pain often radiating to the back; (2) Continuous variables are expressed as the medians and serum lipase activity (or amylase activity) at least three interquartile ranges (IQRs) because they were not nor- times greater than the upper limit of normal; and (3) mally distributed. Categorical variables are expressed as characteristic findings of acute pancreatitis on con- numbers and percentages. The Mann-Whitney test and trast-enhanced computed tomography (CECT) [1]. Fisher exact test were used to compare two variables. http://dx.doi.org/10.3904/kjim.2015.007 www.kjim.org 661 The Korean Journal of Internal Medicine Vol. 31, No. 4, July 2016 Pancreatic lipase 0.6% Endothelial lipase 0.5% The diagnostic performance of serum lipase subtypes was assessed using the receiver-operating characteristic (ROC) curve, which plots sensitivity over 1-specificity. To detect the best cut-off value associated with serum lipase subtype analysis for the prediction of acute pancreatitis, Hepatic lipase a maximum of the Youden index was selected. Multi- 37% variate logistic regression analysis was performed to assess the independent risk factors associated with the Lipoprotein lipase 62% detection of acute pancreatitis. A p < 0.05 (2-tailed) was adopted as the threshold of statistical significance for all of the tests. The analyses were performed using SPSS version 18.0 (SPSS Inc., Chicago, IL, USA), and Medcalc version 13.3.3 (Medcalc Software, Ostend, Belgium). Figure 1. Distribution of each lipase in the total amount of serum lipase subtypes. The relative proportion of mean val- ues in each lipase subtypes are demonstrated. RESULTS Characteristics of patients to 0.005); endothelial lipase, median 0.002 (IQR, 0.001 Of the 34 eligible patients initially enrolled in this study, to 0.003); lipoprotein lipase, median 0.560 (IQR, 0.458 no patients were excluded due to refusal to participate; to 0.721); and hepatic lipase, median 0.432 (IQR, 0.274 to as a result,
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