Fecal Elastase Research Articles

Exocrine Pancreatic Insufficiency in Heart Failure: Clinical Features and Association With Cardiac Cachexia

ABSTRACTBackgroundCardiac cachexia is a complex syndrome, and the underlying mechanisms are not completely understood. Exocrine pancreatic insufficiency (EPI) causes malabsorption, malnutrition and sarcopenia; and might contribute to cardiac cachexia. The prevalence of EPI and its clinical profile in patients with heart failure (HF) remain unknown. The objective of this study is to prospectively examine the prevalence and clinical characteristics of EPI in a wide spectrum of patients with HF and to relate these findings to malnutrition and cardiac cachexia.MethodsExocrine pancreatic function was examined in patients with HF using faecal elastase 1 (FE‐1) measurements. A FE‐1 level of ≤206 μg/g (<200 ± 3%) supported the diagnosis of EPI. All patients were well characterized (including echocardiography and biomarkers); in 36 patients, invasive hemodynamics were measured. Cardiac cachexia was defined as non‐edematous weight loss >5% in at least six months. Malnutrition was assessed by the Simplified Nutritional Appetite Questionnaire (SNAQ). Comparisons were made between patients with and without EPI.ResultsWe enrolled 60 consecutive patients; mean age was 60 ± 10 years, 25 (42%) were women, mean left ventricular ejection fraction (LVEF) was 29 ± 14% and median N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) was 3926 [2126–6645] pg/mL. Six patients (10%) had EPI. They had a lower body weight (61.7 versus 83.0 kg; p = 0.003) and lower BMI (22.3 ± 3.3 versus 26.9 ± 4.5 kg/m2, p = 0.02), but functional class, LVEF and NT‐proBNP were similar (p = 0.53, p = 0.78 and p = 0.97, respectively). Patients with EPI had a higher SNAQ‐score, indicating (more symptoms of) malnutrition (1 [0–3] versus 3 [2–4], p = 0.045). Cardiac cachexia was present in three (50%) of the patients with EPI (versus 26% in patients without EPI, p = 0.35). Patients with EPI exhibited lower serum lipase than patients without EPI (23 [14–25] U/L versus 39 [26–71] U/L, p = 0.003). The aetiology of HF was different between groups (p = 0.016); patients with congenital heart disease appeared to be more often affected by EPI (p = 0.07).ConclusionsEPI is present in a significant proportion of patients with HF but is not associated with conventional HF parameters. Patients with HF and EPI are characterized by lower body weight and BMI, malnutrition and lower plasma lipase. Since EPI is treatable, these findings may have clinical and therapeutic consequences in patients with HF.

Impact of asprosin, interleukin-6, and adiponectin on exocrine pancreatic insufficiency in patients with type 2 diabetes mellitus and chronic pancreatitis

Exocrine pancreatic insufficiency (EPI) is a clinical condition often associated with chronic pancreatitis (CP) and type 2 diabetes mellitus (T2DM) leads to malabsorption and nutritional deficiencies, severely impacting patients’ quality of life. It has been identified that asprosin, a glucogenic protein, is a key player in carbohydrate metabolism and chronic inflammation. Elevated levels of asprosin, along with changes in interleukin‑6 (IL‑6) and adiponectin, may contribute to the pathophysiology of EPI in patients with T2DM and CP. Objective — to investigate the levels of asprosin, IL‑6, and adiponectin and their correlation with exocrine pancreatic function in patients with T2DM and CP. Materials and methods. The study included 100 patients treated at Kharkiv Regional Clinical Hospital from 2020 to 2022. Patients were divided into two groups: Group 1 (n=70) with comorbid T2DM and CP, and Group 2 (n=30) with T2DM alone. The control group included 20 healthy individuals. Blood levels of asprosin, IL‑6, and adiponectin were measured using immunoassays. Fecal elastase‑1 (FE‑1) levels were used to assess exocrine pancreatic function. Pearson’s correlation coefficient was calculated to determine the relationships between these markers. Results. Asprosin levels were significantly higher in Group 1 compared to Group 2 and the control group, with the highest levels observed in patients with comorbid T2DM and CP (10.06±3.56 ng/ml). IL‑6 levels were also elevated in Group 1 (64.44±4.35 pg/ ml), indicating heightened inflammation. Adiponectin levels were lower in Group 1 (2.80±0.38 ng/ml), correlating with worse metabolic profiles. FE‑1 levels were markedly reduced in Group 1 (142.2±6.3 mg/ g), confirming severe EPI. Significant correlations were found between asprosin levels and IL‑6 (positive correlation, r=0.49, p<0.01), as well as between asprosin levels and FE‑1 (negative correlation, r=–0.52, p<0.01). In the group of patients with isolated T2DM, significant moderate negative correlations were found between asprosin levels and adiponectin (r=–0.47, p<0.05) and FE‑1 (r=–0.44, p<0.05). The study also demonstrated a strong negative correlation between adiponectin and IL‑6 (r=–0.61, p<0.01) in patients with comorbid T2DM and CP. Conclusions. Elevated asprosin levels in patients with T2DM and CP are associated with increased inflammation and reduced exocrine pancreatic function. The significant correlations between asprosin, IL‑6, and FE‑1 suggest that asprosin could serve as a clinically valuable biomarker for assessing metabolic and inflammatory status in these patients. The findings highlight the complex interaction between metabolic and inflammatory pathways in the development of EPI.

Prescribing of pancreatic enzyme therapy for malabsorption in unresectable pancreatic cancer: Cross-sectional survey across New Zealand and Australia

ObjectiveTo investigate the practices of clinicians prescribing pancreatic enzyme replacement therapy (PERT) for unresectable pancreatic cancer in Aotearoa New Zealand and Australia. MethodsA mixed media advertising campaign was used to recruit appropriate clinicians to complete a questionnaire that collected demographic data, information regarding prescribed medication, and awareness of PERT guidelines. ResultsThe study recruited 161 clinicians, with 93 and 68 respondents from Aotearoa New Zealand and Australia respectively. Most respondents from both countries were experienced gastrointestinal surgeons and dietitians. Aotearoa New Zealand clinicians and dietitians used faecal elastase more frequently to diagnose PEI than other groups. Clinicians had a tendency to under-prescribe PERT, and to advise incorrectly on the timing of the medication. The majority of clinicians from Aotearoa New Zealand and Australia were not aware of any best practice clinical guidelines for PERT (70 % and 77 %, respectively). ConclusionThis study suggests clinicians are over-reliant on faecal elastase to diagnose PEI and are uncertain about the correct dose and timing of PERT for optimal patient benefit in those with unresectable pancreatic cancer. Most clinicians were not aware of best practice guidelines.

S2030 The Prevalence of Low Fecal Elastase Among Patients With Pancreatic Adenocarcinoma

S2030 The Prevalence of Low Fecal Elastase Among Patients With Pancreatic Adenocarcinoma

Rational Use of Fecal Elastase–1 Testing for Exocrine Pancreatic Insufficiency (EPI)

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Exocrine pancreatic insufficiency in a child with STEC-HUS: a forgotten complication.

Exocrine pancreatic insufficiency (EPI) is an extremely rare complication of hemolytic uremic syndrome related to Shiga toxin-producing Escherichia coli (STEC-HUS) and, to our knowledge, only one patient has been reported to have received pancreatic enzyme replacement therapy (PERT). Furthermore, STEC-HUS is not usually included among EPI causes. We report a 4-year-old girl with STEC-HUS who required dialysis and 4days after admission developed acute pancreatitis (ACPAN) and diabetes mellitus (DM). Amylase and lipase normalized 15days later but on the 73rd day of admission, she presented abdominal discomfort, bloating, and bulky and malodorous stools with a low fecal elastase-1 level (FE-1) of 15.74µg/g confirming EPI diagnosis. She received 3months of PERT until normalization of FE-1 levels. In children with STEC-HUS with ACPAN or DM, a high index of suspicion for EPI is required, since its symptoms are often mild, nonspecific, or delayed. In addition, STEC-HUS should be further recognized as a cause of secondary EPI.

407. MICRONUTRIENT INSUFFICIENCY AFTER SURGERY FOR OESOPHAGOGASTRIC NEOPLASMS: A PROSPECTIVE INTERVENTION STUDY CALLED THE VITAMIN STUDY

Abstract Background Oesophageal and gastric cancer have major impact on nutritional status and quality of life (QoL). Preoperative malnutrition is reported in 42–80%. However, studies investigating postoperative nutritional status are scarce and postoperative identification and treatment of micronutritional deficiencies are currently lacking in (inter-)national guidelines. The aim of this study is to identify micronutrient deficiencies after surgery for oesophagogastric neoplasms and target them by supplementation. Methods This is a recently closed multicenter trial in the Netherlands. Patients receive a tailormade multivitamin supplement which differs per group and a calcium supplement. Baseline measurements consist of blood withdrawal, faecal elastase-1 (FE-1) analysis, QoL questionnaires and dietary behaviour. After 6 (T=1), 12 (T=2) and 24 (T=3) months from baseline, measurements are repeated, and a supplement questionnaire is added. The primary objective is micronutrient deficiency (yes/no). Secondary objectives include occurrence and symptoms of exocrine pancreas insufficiency (EPI) and QoL. Results Inclusion spanned from December 2021 to December 2023. Preliminary results from 95 patients are available, whereby 68 patients underwent oesophagectomy and 27 gastrectomy. Of these, 55 patients received 6 months of supplementation (T=1). At T=0, 77.0% had at least one micronutrient deficiency. Identified deficiencies are shown in table 1. Deficiencies were more common in patients undergoing gastrectomy compared to those undergoing oesophagectomy (88.0% vs. 72.1%). Reduced FE-1 (<200 mg/kg) was found in 22.2% at baseline and 26.7% at T=1. 16.7% experienced EPI symptoms at baseline, which resolved at follow-up. Conclusion The most common micronutrient deficiencies decreased substantially after 6 months of supplementation. The follow-up extends until November 2024. Routine monitoring and supplementation could potentially be implemented in standard postoperative care for gastric and oesophageal cancer.

Diagnostic Transitions of Cystic Fibrosis and CRMS Compared After 12 Years of Newborn Screening in California

To compare the long-term diagnostic transitions for cystic fibrosis (CF) and CF-Related Metabolic Syndrome (CRMS) side-by-side during follow-up since the onset of newborn screening in California. Using real-world data, we conducted a retrospective cohort study to compare long-term observations of CRMS and CF in California and the diagnostic transitions from one to the other using clinical and diagnostic metrics. The California Genetic Disease Screening Program (GDSP) newborn screening for CF employs an immunoreactive trypsinogen tier-1 laboratory test, followed by molecular testing. This approach captures CF and CRMS, a diagnosis of "watchful waiting" among infants at risk for CF but with signs and symptoms that may emerge outside the screening window. Waiting entails periodic diagnostic reviews that can continue for many years; GDSP routinely conducts five years of follow-up for each child identified with a disorder. We utilized categorial logistic regression to compare the transitions with CRMS. After screening 5,944,700 newborns between July 2007 and July 2019, 694 CF cases and 1,258 CRMS cases were identified. Of the 1,258 CRMS cases, 66 (5.2%, 95% CI=3.9%,6.4%) transitioned from CRMS to CF (CRMS2CF) at a mean age of 3.3 years (median=2.9 years). CRMS2CF cases had longer follow-up periods and were more likely later to develop positive sweat chloride and fecal elastase test results after 6 months of life than other CRMS cases. These results suggest that children who have a CRMS2CF transition are more likely to develop positive biochemical markers than other CRMS patients and have few clinical indications during the first five years of follow-up.

Exokrinní pankreatická nedostatečnost – klinická praxe roku 2024

Summary Exocrine pancreatic insufficiency (EPI) is characterized by insufficient secretion of pancreatic digestive enzymes. According to the mechanistic theory, the lack of pancreatic enzymes in the small intestine does not ensure the digestion of food, which is mainly associated with the lack of essential fatty acids and liposoluble vitamins and, as a result, leads to the inability to ensure the nutritional and metabolic needs of the organism. In diagnostics, the standard is determination of fecal elastase. This determination is simple, the limitation is the low sensitivity to determine possible changes in pancreatic function already in the so-called initial stages of the dis ease. An alternative to fecal elastase testing is the use of breath tests using a mixture of triglycerides, radioactively labeled with carbon C13. Although the test is non-invasive, it is time-consuming and more difficult to access. The clinical symptoms of EPI are mainly those related to microbial digestion and subsequent malabsorption/maldigestion of micro- and macronutrients. In addition to the subjective feeling of bloating, borborygmy or osmotic diarrhea, low levels of liposoluble vitamins and some trace elements are frequent findings. Osteoporosis or sarcopenia belong to the picture of EPI. In EPI therapy, diet therapy and pancreatic enzyme replacement are essential approaches. The principle is to administer an adequate dose, especially of pancreatic lipase: 40,000–50,000 units with main meals, with application during meals. Smaller meals (snacks) are substituted with half the dose. The optimal galenic form is capsules with a protective cover, against the inactivation of enzymes by gastric acid, before they enter the duodenum. The galenic form is capsules containing enzymes in microparticles, 1.0–2.0 mm in size, which are released from the capsule upon entering the duodenum. This is the so-called controlled synchronization of the liberalization of the enzymes contained in the capsule. EPI is an underdiagnosed and undertreated condition in the population. The control of patients must therefore include, in addition to the evaluation of the overall clinical condition, the monitoring of changes that may manifest malabsorption. It is recommended to monitor the nutritional status at least once a year, at regular intervals. Keywords exocrine insufficiency, maldigestion, malabsorption, fecal elastase, osteoporosis, osteopenia, pancreatic replacement, microparticle capsules

Long-Term Impact of Lumacaftor/Ivacaftor Treatment on Cystic Fibrosis Disease Progression in Children 2 Through 5 Years of Age Homozygous for F508del-CFTR: A Phase 2, Open-Label Clinical Trial.

Clinical trials show that lumacaftor/ivacaftor (LUM/IVA) treatment has the potential to modify early cystic fibrosis (CF) disease progression in children as young as 2 years of age. To assess the long-term impact of LUM/IVA treatment on CF disease progression in children aged 2 through 5 years. This phase 2 trial had two parts: Part 1, a 48-week, randomized, double-blind, placebo-controlled study of LUM/IVA in children aged 2 through 5 years (previously reported) was followed by a 48-week open-label treatment period where all children received LUM/IVA (Part 2; reported here). Endpoints assessed in Part 2 included absolute changes from baseline in chest magnetic resonance imaging (MRI) global score at week 96; weight-for-age, stature-for-age, and body mass index (BMI)-for-age z-scores at week 96; lung clearance index (LCI2.5) through week 96; chest MRI morphological score, chest MRI perfusion score, weight, stature, BMI, and microbiology cultures (oropharyngeal swabs) at week 96; sweat chloride, serum levels of immunoreactive trypsinogen, fecal elastase-1 levels, and fecal calprotectin through week 96; and number of pulmonary exacerbations (PEx), time-to-first PEx, and number of CF-related hospitalizations. Forty-nine children received ≥1 dose of LUM/IVA in the open-label period (33 in the LUM/IVA to LUM/IVA group and 16 in the placebo to LUM/IVA group); mean exposure 47.1 (SD, 5.2) weeks. The mean absolute change in MRI global score (negative value = improvement) from baseline at Week 96 was -2.7 (SD 7.0; 95% CI, -5.2 to -0.1) in the LUM/IVA to LUM/IVA group and -5.6 (SD 6.9; 95% CI, -9.2 to -1.9) in the placebo to LUM/IVA group. Improvements in LCI2.5, sweat chloride concentration, and markers of pancreatic function and intestinal inflammation were also observed in both groups. Growth parameters remained stable in both groups. The majority of children had adverse events (AEs) considered mild (38.8%) or moderate (40.8%). Two (4.1%) children discontinued LUM/IVA treatment due to AEs (distal intestinal obstruction syndrome [n=1] and alanine aminotransferase increase [n=1]). These findings confirm the potential for early LUM/IVA treatment to alter the trajectory of CF disease progression, including CF lung disease, in children as young as 2 years of age. Clinical trial registration available at www. gov, ID: NCT03625466.

Correlation between endoscopic ultrasound features and exocrine pancreatic function in chronic pancreatitis

BackgroundEndoscopic ultrasound (EUS) is the most sensitive method for diagnosing chronic pancreatitis (CP) in its early stages, and Rosemont Classification (RC) is used for its evaluation. Data on the correlation between EUS features and pancreatic exocrine insufficiency (PEI) are limited. We investigated the correlation between the EUS findings and PEI. MethodsThis was a retrospective, monocentric cohort study involving patients prospectively enrolled from 2018 to 2022, with definite or probable CP according to the M-ANNHEIM criteria. All the patients underwent EUS and exocrine function investigations within 12 months of diagnosis. PEI was diagnosed using fecal elastase (FE) or when overt steatorrhea was reversed by pancreatic enzyme replacement therapy. Logistic regression analyses, rank correlation, ROC curve, and area under the curve (AUROC) were performed to evaluate the association between EUS features and PEI, and the accuracy of RC in predicting PEI. ResultsAmong 128 patients examined (63.3 % male; mean age, 47 years), 69.5 % were diagnosed with PEI. In multivariate logistic regression among all the RC criteria, only lithiasis in the main pancreatic duct (MPD) was associated with increased risk of PEI (OR 2.92, 95 % CI 1.29–6.61; p = 0.01). Rank analysis showed a weak inverse correlation between RC and FE (Spearman's rho = −0.02; p = 0.03). The accuracy of RC was moderate (AUROC 0.62, p = 0.014). ConclusionsAmong RC EUS features, lithiasis in the MPD is helpful for predicting the risk of PEI, while other findings are of limited utility in evaluating exocrine function.

Prevalence of exocrine pancreatic insufficiency at 12 months after acute pancreatitis: a prospective, multicentre, longitudinal cohort study

Exocrine Pancreatic insufficiency (EPI) occurs following acute pancreatitis (AP) at variably reported rates and with unclear recovery timeline. The aim of this study was to establish the prevalence and predictors of EPI at 12 months after AP in a prospective cohort. In this prospective, multicentre, longitudinal cohort study, adult participants (≥18 years) admitted to the hospital with an AP attack (defined by Revised Atlanta Classification) were enrolled in a United States multi-centre longitudinal cohort (Sites: The Ohio State University, University of Pittsburgh, and Johns Hopkins University). Patients were excluded if they had pancreatic cancer, chronic pancreatitis, or malabsorptive disease (including previously diagnosed EPI). Participant data was obtained by interview and by review of the electronic medical record. EPI was assessed by stool fecal elastase (FE-1) levels collected at baseline, 3 months, and 12 months (primary endpoint). EPI was defined by FE-1 <200μg/g; severe FE-1 level ≤100μg/g; mild FE-1 101-200μg/g. Multivariable logistic regression was used to identify predictors of EPI at 12 months. This study is registered with ClinicalTrials.gov, NCT03063398. EPI was observed in 29 (34.1%) of the 85 participants [44 (51.8%) male, mean age 54.7±14.1 years] who provided stool samples at 12 months. For the study overall, participants were recruited between June 22, 2017 and October 18, 2021. A total of 5794 individuals were screened, 311 of whom were eligible for the study. 112 participants provided stool samples at baseline, 79 completed stool samples at 3 months, and 85 completed samples at 12 months. 64 participants included samples at all 3 timepoints. In univariable analysis, factors significantly associated with EPI at 12 months included recurrent (versus index) AP, pre-existing diabetes, alcohol, and idiopathic etiologies, and increasing severity of AP. In multivariable analysis, the odds of having EPI at 12 months increased 4-fold with idiopathic AP etiology (Odds Ratio 4.095, 95% Confidence Interval [CI] 1.418, 11.826), and 3-fold with moderately severe or severe AP (Odds Ratio 3.166, 95% CI 1.156, 8.670), and baseline diabetes mellitus (Odds Ratio 3.217, 95% CI 1.113, 9.298). Even individuals with an index mild attack of AP (n=39) developed severe EPI at 12 months (prevalence 12.8%). EPI as diagnosed by FE-1 is present in over one third of prospectively assessed patients at 12 months post-AP. Since EPI develops in patients with mild AP, investigations are needed to understand the mechanisms of injury and identify methods for tailored screening. This study was supported by an Investigator Initiated Research Grant from AbbVie, Inc.

Glycemic variability in chronic calcific pancreatitis with diabetes mellitus and its possible determinants

AimsTo study glycemic patterns and variability in patients with pancreatic diabetes or type 3c Diabetes mellitus (DM) due to chronic pancreatitis and its subtypes and assess the role of pancreatic enzyme replacement therapy (ERT) in modulating glycemic variability. MethodsPatients having type 3c DM due to chronic pancreatitis, and on insulin underwent Flash continuous-glucose-monitoring (CGM) for 14 days. Parameters were compared between patients with fibrocalculous pancreatic diabetes (FCPD) and non-FCPD-chronic calcific pancreatitis (non-FCPD) and between the recipients and non-recipients of pancreatic enzyme-replacement-therapy (ERT). ResultsOut of 54 patients with pancreatic diabetes, 35 patients had chronic calcific pancreatitis. They underwent CGM, median HbA1c 9.20 % (77 mmol/mol) and mean Time-In-Range (TIR) being 41.21 % (23.48). Only 5 (15.2 %) patients achieved target TIR>70 % while 16 (48.5 %) patients had high glycemic-variability [Coefficient-of-variation (CV) > 36 %]. Patients with FCPD (n = 14) had higher hypoglycemia-indices like Time-Below-Range (18.92 % vs 8.20 %; p = 0.03) and Low-Blood-Glucose-Index (18.14 % vs 6.04 %; p = 0.02) compared to non-FCPD (n = 21). HbA1c% and hyperglycemic excursions were similar in both groups. Recipients of ERT (n = 20) had lower glycemic-variability [Standard Deviation (SD) 52.15 % vs 68.14 % and CV 32.59 % vs 41.79 %, p < 0.05 for both) than non-recipients. ERT-recipients had no serious hypoglycemia within the 14 days. On subgroup analysis, lower glycemic-variability and hypoglycemia with ERT were seen only in FCPD but not in non-FCPD subgroup (50.13 vs 77.91, 30.09 vs 48.36 for SD and CV respectively, p < 0.05). ConclusionPatients with type 3c DM due to chronic pancreatitis have high frequency of hyperglycemic and hypoglycemic excursions, with those with FCPD having a particularly higher risk of hypoglycemia and glycemic-variability. Those receiving pancreatic ERT had lesser glycemic variability and hypoglycemia. The small sample size and lack of objective markers of documentation of exocrine pancreatic insufficiency like fecal elastase highlight the need for further larger studies in this field.

Developing the EPI Symptom Questionnaire (EPI-SQ): a qualitative study to understand the symptom experience of patients with exocrine pancreatic insufficiency (EPI)

BackgroundSymptom assessment is the key factor in determining disease status and optimal management of exocrine pancreatic insufficiency (EPI). There is a need for a standardized patient-reported outcome (PRO) questionnaire to assess symptoms in patients diagnosed with EPI. The purpose of this qualitative study was to increase understanding of the EPI symptom experience from the patients’ perspective, and to develop and evaluate the content validity of the EPI Symptom Questionnaire (EPI-SQ) in US patients with EPI.MethodsConcept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants’ understanding of the instructions, items, response scales, and recall periods of the instrument.ResultsDuring Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended.ConclusionThe qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.

Clinical and Analytical Comparison of Monoclonal and Polyclonal Immunoassays for Fecal Pancreatic Elastase.

Numerous immunoassays have been commercialized to determine pancreatic elastase (PE) in feces in screening for exocrine pancreatic insufficiency (EPI), but how the different assays compare to one another is controversial, especially in the context that all methods use the same cut-off values for interpreting the results obtained on the presence or absence of EPI or the degree of insufficiency if it is present. Our aim was to analytically verify a new method for determining PE, compare the results with a previous method, and verify the declared cut-off values for interpretation of the results. PE in the stool was assayed using a previous monoclonal enzyme-linked immunosorbent assay ("ScheBo ELISA") and a new polyclonal particle-enhanced turbidimetric immunoassay ("Bühlmann PETIA"). The direct method comparison of two immunoassays was performed in 40 samples. Clinical comparisons were conducted against each other for the binary determination of "abnormal/normal" elastase levels and the three-way determination of "severe/moderate/no" EPI in 56 samples. The indirect comparison method used external quality assessment (EQA) data to compare the monoclonal and polyclonal immunoassays for PE, and additionally compare the monoclonal ScheBo ELISA to a monoclonal chemiluminescence immunoassay ("DiaSorin CLIA"). Precision in the series and intra-laboratory precision for Bühlmann PETIA met the manufacturer's specifications for the concentration range of limit/lower values and the range of normal values. The Bühlmann PETIA immunoassay on different analytical platforms yielded comparable results and nearly perfect agreement in the case of three-way classification (kappa = 0.89 with 95%CI from 0.79 to 1.00. ScheBo ELISA tends to generate higher values of pancreatic elastase than the Bühlmann PETIA; agreement between the methods was moderate in the case of binary classification (kappa = 0.43; 95% CI 0.25 to 0.62), and substantial in the case of three-way classification (kappa = 0.62; 95% CI 0.50 to 0.75). EQA data analysis showed a statistically significant difference between ScheBo ELISA and Bühlmann PETIA peer groups (p = 0.031), as well as the DiaSorin CLIA and ScheBo ELISA peer groups (p = 0.010). The ScheBo ELISA and Bühlmann PETIA do not appear to be commutable in the analytical and clinical context. Our data address a discordance between different mono- and polyclonal immunoassays for pancreatic elastase and the potential of misclassification using its universal cut-off values in screening suspected patients for exocrine pancreatic insufficiency.

Diagnostic Efficacy of Fecal Elastase-1 in Patients with Chronic Pancreatitis Diagnosed by Endoscopic Ultrasound

Diagnostic Efficacy of Fecal Elastase-1 in Patients with Chronic Pancreatitis Diagnosed by Endoscopic Ultrasound

Screening for undiagnosed pancreatic exocrine insufficiency (PEI) in a cohort of diabetic patients using faecal elastase testing and PEI scoring system.

Type 1 and type 2 diabetes mellitus (DM) are often accompanied by mild forms of pancreatic exocrine insufficiency (PEI). The prevalence rates of PEI in diabetic patients are unclear and variable depending on the testing modality and the studies published. The clinical consequences of PEI in diabetics are also not well defined. We aimed to determine the prevalence of PEI in a diabetic cohort using the faecal elastase-1 (FE-1) assay as a screening test and to validate a patient-reported symptom-based scoring system, the (PEI-S) for diagnosing PEI within this patient population. Two hundred and three diabetic patients attending diabetic and gastroenterology outpatients of a university hospital without previously known PEI were recruited for the study. Demographic parameters, PEI score (PEI-S), and glycated hemoglobin (HBA1c) were documented in standardized data sheets, and a stool sample was obtained. A FE-1 value < 200μg/g and or a PEIS of > 0.6 was used as the screening cut-off for PEI. One hundred sixty-six patients returned faecal samples. The prevalence of PEI, as measured by low FE-1, was 12%. Smoking was associated with an increased risk of developing PEI in this diabetic population. No other independent risk factors were identified. The PEI-S system did not differentiate between people with diabetes having a normal and low FE1. 12% of this mixed, real-life cohort of type 1 and 2 DM patients had undiagnosed PEI, as defined by an FE-1 score of less than 200μg/g. While this may appear low, given the rising prevalence of type 2 DM worldwide, there is likely an unrecognized burden of PEI, which has long-term health consequences for those affected. The PEI-S, a symptom-scoring system for patients with PEI, did not perform well in this patient group.

Applicability of the Pancreatic Exocrine Insufficiency Test (PEI-TEST) in Pediatric Patients.

In mild cases, it is difficult to diagnose pancreatic exocrine insufficiency (PEI). There is no gold standard method for the diagnosis of PEI. A reliable method is needed for preliminary diagnosis of PEI. The PEI-TEST was applied to the patients with nonspecific gastrointestinal complaints. Serum amylase, lipase, serum trypsinogen, and fecal elastase 1 (FE-1) were analyzed from each patient. According to the PEI-TEST, PEI was present in 42 (47.7%) and PEI was not present in 46 (52.3%) patients. No significant difference was observed between the 2 groups with regard to age, gender and amylase, lipase, serum trypsinogen, and FE-1. When an FE-1 value of <200 µg/dL was considered as indicating PEI, the sensitivity and specificity of the test were found to be 47.4% and 52.2%, respectively. Although it is promising that PEI-TEST is a validated test in our country and suitable for our society, it is not suitable for pediatric patients.

Clinical performance of a turbidimetric immunoassay for the quantification of fecal pancreatic elastase

Clinical performance of a turbidimetric immunoassay for the quantification of fecal pancreatic elastase

ARTERIAL STIFFNESS ASSOCIATES WITH MALNUTRITION IN HYPERTENSIVE PATIENTS WITH CONCOMITANT CHRONIC PANCREATITIS

Objective: The association between pancreatitis and cardiovascular diseases remains incompletely understood. Malnutrition in chronic pancreatitis may be associated with an increase in arterial stiffness in hypertension. Objective: to evaluate interaction between malnutrition markers and arterial stiffness in patients with hypertension and chronic pancreatitis. Design and method: Methods: 70 non-diabetic patients with 1st degree hypertension with concomitant chronic pancreatitis (median age – 52,4 [43,8;63,7] years) were included in the study. We divided all included patients into two groups: 1st group – 41 patients with malnutrition, 2nd group – 29 patients without malnutrition. Standard laboratory blood tests, haematological parameters, lipid profile, glucose, renal and liver function tests, pancreatic fecal elastase-1, total protein, serum albumin, serum iron, vitamin 25(OH)D, serum zinc and magnesium detection were performed for all patients. The groups were comparable in terms of age, gender structure, functional state of the kidneys. Non-parametric methods were used for statistical data analysis. To determine the prognostic significance, the ROC analysis was performed. Significant differences were considered when the p-value was p&lt;0.001 Results: In patients with a combined course of hypertension and chronic pancreatitis with established malnutrition, an increase in arterial stiffness was significantly more often compared to patients with normal nutritional status - 83% and 62%, respectively (p&lt;0.001). A significantly lower level of brachial artery augmentation index was established by 43% (p&lt;0.001) in the first group. It was established that patients with malnutrition had a significantly higher caritid-femoral pulse wave velocity by 17.5% (p&lt;0.001). Correlations were established between brachial artery augmentation index and serum levels of zinc (R=0.63, p&lt;0.001), magnesium (R=0.66, p&lt;0.001), albumin (R=0.58, p&lt;0.001), vitamin 25(OH)D (R=0.68, p&lt;0.001) in patients with the combined course of hypertension and chronic pancreatitis. ROC analysis revealed that serum zinc level had an excellent diagnostic power for arterial stiffness in hypertensive patients with chronic pancreatitis (AUC = 0.910). Serum albumin had very good diagnostic power for arterial stiffness in hypertensive patients with chronic pancreatitis (AUC = 0.859). Conclusions: Arterial stiffness may be associated with malnutrition in hypertensive patients with concomitant chronic pancreatitis.