Exocrine Pancreatic Insufficiency In Patients Research Articles

Development of clinical screening tool for exocrine pancreatic insufficiency in patients with definite chronic pancreatitis

Background/ObjectivesNo simple, accurate diagnostic tests exist for exocrine pancreatic insufficiency (EPI), and EPI remains underdiagnosed in chronic pancreatitis (CP). We sought to develop a digital screening tool to assist clinicians to predict EPI in patients with definite CP. MethodsThis was a retrospective case-control study of patients with definite CP with/without EPI. Overall, 49 candidate predictor variables were utilized to train a Classification and Regression Tree (CART) model to rank all predictors and select a parsimonious set of predictors for EPI status. Five-fold cross-validation was used to assess generalizability, and the full CART model was compared with 4 additional predictive models. EPI misclassification rate (mRate) served as primary endpoint metric. Results274 patients with definite CP from 6 pancreatitis centers across the United States were included, of which 58 % had EPI based on predetermined criteria. The optimal CART decision tree included 10 variables. The mRate without/with 5-fold cross-validation of the CART was 0.153 (training error) and 0.314 (prediction error), and the area under the receiver operating characteristic curve was 0.889 and 0.682, respectively. Sensitivity and specificity without/with 5-fold cross-validation was 0.888/0.789 and 0.794/0.535, respectively. A trained second CART without pancreas imaging variables (n = 6), yielded 8 variables. Training error/prediction error was 0.190/0.351; sensitivity was 0.869/0.650, and specificity was 0.728/0.649, each without/with 5-fold cross-validation. ConclusionWe developed two CART models that were integrated into one digital screening tool to assess for EPI in patients with definite CP and with two to six input variables needed for predicting EPI status.

Inhibition Effect of Pancreatic Exocrine Insufficiency on Immune Checkpoint Inhibitor Treatment in Pancreatic Cancer: A Retrospective Study.

Chemotherapy combined with immune checkpoint inhibitors (ChIM) is used to treat advanced pancreatic ductal adenocarcinoma (PDAC). However, the efficacy of ChIM is similar to that of chemotherapy alone. To assess potential factors affecting the effectiveness of ChIM, we analyzed the clinical data of 359 patients with PDAC who visited the hospital during June 2017 to December 2022. Surgical resection, diabetes, and ChIM were risk factors for pancreatic exocrine insufficiency (PEI). The adjusted odds ratio of ChIM was 2.63 (95% confidence interval (CI) 1.492-4.626) (P = 0.001). The incidence of PEI in the ChIM group (76.9%) was significantly higher than that of the chemotherapy group (60.2%) (P = 0.004). Survival analysis showed that ChIM did not improve the survival rate of patients with PDAC (hazard ratio (HR) 0.92, 0.707-1.197) (P = 0.534) in comparison with that of the chemotherapy group. However, in patients without PEI, those receiving ChIM showed a higher 1-year overall survival (OS) rate of 70.8% (two-sided, P = 0.045) and a median OS of 22.0 months (95% CI 11.5-32.5). Moreover, pancreatic enzyme replacement therapy significantly improved the OS of patients with PDAC (HR = 0.73, 95% CI = 0.561-0.956) (P = 0.022). Immune checkpoint inhibitors (ICIs) increased the incidence of PEI in patients with PDAC. The OS was not different between patients receiving chemotherapy and ChIM due to irregular PERT treatment. The finding show that pancreatic enzyme replacement therapy may improve the response rate of patients with PDAC to ICIs.

Predictive Insights Into Exocrine Pancreatic Insufficiency in Chronic Pancreatitis and Autoimmune Pancreatitis: A Decision Tree Approach.

Exocrine pancreatic insufficiency (EPI) is a common manifestation of chronic pancreatitis (CP) and autoimmune pancreatitis (AIP). This study aimed to estimate the presence of EPI in patients with CP or AIP using alternative clinical markers. A machine learning analysis employing a decision tree model was conducted on a retrospective training cohort comprising 57 patients with CP or AIP to identify EPI, defined as fecal elastase-1 levels less than 200 μg/g. The outcomes were then confirmed in a validation cohort of 26 patients. Thirty-nine patients (68%) exhibited EPI in the training cohort. The decision tree algorithm revealed body mass index (≤21.378 kg/m 2 ) and total protein level (≤7.15 g/dL) as key variables for identifying EPI. The algorithm's performance was assessed using 5-fold cross-validation, yielding area under the receiver operating characteristic curve values of 0.890, 0.875, 0.750, 0.625, and 0.771, respectively. The results from the validation cohort closely replicated those in the training cohort. Decision tree analysis revealed that EPI in patients with CP or AIP can be identified based on body mass index and total protein. These findings may help guide the implementation of appropriate treatments for EPI.

Features of exocrine pancreatic insufficiency in patients with non-alcoholic fatty liver disease in combination with type 2 diabetes and COVID-19.

Aim: The aim of the research was to study the features of pancreatic exocrine insufficiency (EPI) in patients with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (DM) at COVID-19. Materials and Methods: 72 patients with NAFLD and COVID-19 were examined. The patients have been divided into two groups: group 1 included 42 patients with NAFLD and insulin resistance (IR); group 2 consisted of 30 patients with NAFLD in the combination with type 2 DM. EPI was detected by 13С-mixed triglyceride breath test (13С-MTBT) in all the patients. Results: The result of 13С-MTBT indicates EPI in the examined subjects of the 2 group. A significant decrease in the maximum concentration of 13СО2 between 150 and 210 min was also diagnosed in group 1 patients. research (up to 8.2 ± 0.9% - p < 0.05), however, the total concentration of 13СО2 at the end of 360 min. the study reached only 27.7 ± 1.1% (p < 0.05). Conclusions: Based on the results of laboratory-instrumental methods of research, patients with NAFLD and type 2 diabetes with COVID-19 were diagnosed with severe EPI. The results of 13С-MTBT in NAFLD and IR with COVID-19 indicate a decrease in the functional reserves of the pancreas and the formation of its EPI.

Comprehensive, long-term evaluation of pancreatic exocrine insufficiency after pancreatoduodenectomy

AimsTreatment of pancreatic exocrine insufficiency (PEI) following pancreatoduodenectomy (PD) improves quality of life, clinical outcomes, and survival. However, diagnosing PEI following PD is challenging owing to the difficulties with current tests and often non-specific symptoms. This work aims to quantify the true rate of long-term PEI in patients following a PD. MethodsPatients underwent a PEI screen approximately one to two years following PD for oncologic indication, including the 13C Mixed triglyceride breath test (13CMTGT), faecal elastase 1 (FE-1) and the PEI Questionnaire (PEI-Q). Four reviewers with expertise in PEI reviewed the results blinded to other decisions to classify PEI status; disagreements were resolved on consensus. Results26 patients were recruited. Of those with valid test results, these were indicative of PEI based on pre-specified thresholds for 60 % (15/25) for the 13CMTGT, 82 % (18/22) for FE-1, and 88 % (22/25) for the PEI-Q. After discussion between reviewers, the consensus PEI prevalence was 81 % (95 % CI: 61–93 %; 21/26), with 50 % (N = 13) classified as having severe, 23 % (N = 6) moderate, and 8 % (N = 2) mild PEI. DiscussionSince no ideal test exists for PEI, this collation of diagnostic modalities and blinded expert review was designed to ascertain the true rate of long-term PEI following PD. This required our cohort to survive a year, travel to hospital, and undergo a period of starvation and PERT hold, and therefore there is likely to be recruitment bias towards fitter, younger patients with less aggressive pathology. Despite this, over 80 % were deemed to have PEI, with over 90 % of these being considered moderate or severe.

OGC P16 Pancreatic Exocrine Insufficiency after Oesophagogastric Resection: Results from a Systematic Review and Meta-Analysis

Abstract Background Unpleasant gastrointestinal complications can affect 9/10 patients after oesophagogastric resection (OGR), and malnutrition is recognised in this cohort. Untreated pancreatic exocrine insufficiency (PEI) results in substantial patient harm and is recognised as a contributor to such symptoms. The incidence of post-operative PEI is unclear, however and the benefit of management with pancreatic enzyme replacement therapy (PERT), rarely discussed. The aim of this study was to assimilate the literature on incidence, diagnosis, and management of PEI in patients following OGR. Methods A systematic review of PUBMED and Embase databases identified studies investigating PEI following OG resection. A pooled analysis was performed to determine prevalence of PEI in each cohort, and benefit of PERT. Meta-analyses were performed using the software package Revman 5.4, in accordance with the recommendation of the Cochrane Collaboration. Results Twelve studies were included in the quantitative synthesis of PEI rate after OGR surgery. The rate of PEI after any OGR was 50.4% (95% CI: 38.3% - 62.6%) amongst 463 patients. PEI was most prevalent after total gastrectomy at 66.2% (95% CI: 44.9% - 84.9%) followed by subtotal, 46.9% (95% CI: 33.3% - 60.9%) and oesophagectomy 31.0% (95% CI: 17.0% - 46.9%) The most common diagnostic test used was faecal-elastase-1 (FE-1) (4/12 studies) reporting &amp;lt;200 µg/g as diagnostic of PEI. Four studies reported the effect of PERT, with symptomatic benefit seen in 75.2% (95% CI: 66.9% - 82.7%). Conclusions PEI is common following OGR, with over half of patients developing PEI. The presence of PEI reduces quality of life, contributes to malnutrition and long-term poor health, but can be managed effectively with PERT. Future work must further define the role of PERT after OGR, considering not only nutritive and qualitative benefit, but also whether a survival advantage is conferred.

BS O02 Pancreatic Exocrine Insufficiency after Bariatric Metabolic Surgery: Results from a Systematic Review and Meta-Analysis

Abstract Background Disruptive gastrointestinal symptoms and malnutrition are common following bariatric metabolic surgery (BMS), and pancreatic exocrine insufficiency (PEI) is a sparsely considered cause of such. Untreated PEI results in substantial patient harm and should be managed with pancreatic enzyme replacement therapy (PERT). The incidence of PEI, its diagnosis and management, is unclear after BMS. The aim of this review was to assimilate the literature on incidence, diagnosis, and management of PEI in patients following BMS. Methods A systematic review of PUBMED and Embase databases identified studies investigating PEI following BMS. A pooled analysis was performed to determine prevalence of PEI in each cohort, and benefit of PERT. Meta-analyses were performed using the software package Revman 5.4, in accordance with the recommendation of the Cochrane Collaboration. Results 12 studies were included in the quantitative synthesis of PEI rate after BMS. The rate of PEI after any BMS was 23.0% (95% CI:14.6% - 32.6%) amongst 1157 patients, and most common after biliopancreatic diversion with duodenal switch (44.0% (95%CI: 9.2-82.1%)). The most common diagnostic test used was faecal-elastase-1 (FE-1) (10/12 studies) reporting &amp;lt;200 µg/g as diagnostic of PEI. Five studies considered management of PEI with 81.7% (95% CI: 73.8% - 88.6%) of patient’s responding positively to PERT when prescribed. One study specifically reported improved Vitamin D, quality of life and FE-1 following PERT, with no effect on weight loss. Conclusions PEI is common following BMS, particularly following bypass procedures, and may be a substantial contributor to post-operative malnutrition in these patients. With over 4/5th patients experiencing symptomatic benefit of PERT, and evidence suggesting it does not prohibit weight loss, future research must further illuminate the role of PERT in the post-operative story of BMS patients.

Peculiarities of the formation of exocrine pancreatic insufficiency in patients with primary osteoarthritis under conditions of comorbidity

Summary. The comorbidity of primary OA and diseases of the gastrointestinal tract, which EPI accompanies, is an extremely relevant, complex, and unstudied problem of modern medicine, as it has a number of unsolved problems both in the treatment and rehabilitation of such patients. Common pathogenetic mechanisms of the progression of such comorbidity often have a mutually aggravating effect, which requires further study.&#x0D; The aim of the study is to analyze the changes in indicators of exocrine pancreatic insufficiency (EPI) in patients with primary OA under the conditions of comorbidity with diseases of the gastrointestinal tract (GI).&#x0D; Research material and methods. 304 patients with primary OA in comorbidity with diseases of the gastrointestinal tract accompanied by non-exacerbation EPI were examined. The comparison group consisted of 30 practically healthy individuals who did not have clinical, anamnestic, and instrumental signs of diseases of the gastrointestinal tract and joints.&#x0D; Results and discussion. It was established that in patients with primary OA in comorbidity with diseases that are accompanied by EPI, the levels of EPI indicators were statistically significantly different depending on the etiology of EPI.&#x0D; Conclusion. Post hoc analysis established the ranking of the pathology of the gastrointestinal tract, accompanied by EPI, according to the indicators of EPI in primary OA, which was located as follows, starting from the highest: CP ˃ T2DM ˃ chronic non-calculous cholecystitis and functional diseases of the gallbladder and biliary system ˃ chronic gastroduodenitis (p ˂0.05).

Are we missing pancreatic exocrine insufficiency in ‘at-risk’ groups? Prospective assessment of the current practice and yield of faecal elastase testing in patients with diabetes mellitus, HIV and/or high alcohol intake

There is cumulative evidence that pancreatic exocrine insufficiency (PEI) is under-recognised and can occur in patients with ‘at-risk’ conditions. Thus, we aimed to assess the current practice and yield of requesting faecal elastase (FEL-1), an indicator of PEI, in patients with ‘at-risk’ conditions. We prospectively recruited patients attending secondary care clinics with diabetes mellitus (DM), people living with HIV (PLHIV) and inpatients admitted to hospital with high alcohol intake (HAI). All patients underwent testing with FEL-1. Those patients with PEI (FEL-1 <200 μg/g) were contacted and offered a follow-up review in gastroenterology clinic. In total, 188 patients were recruited (HAI, n=78; DM, n=64; and PLHIV, n=46). Previous FEL-1 testing had not been performed in any of the patients. The return rate of samples was 67.9% for patients with HAI, 76.6% for those with DM and 56.5% for those with PLHIV. The presence of PEI was shown in 20.4% of patients with DM, 15.4% of patients with PLHIV and 22.6% in those with HAI. Diarrhoea and bloating were the most reported symptoms in followed-up patients with low FEL-1 (31.8% and 22.7% of patients, respectively). Follow-up computed tomography (CT) scans in those patients with PEI identified chronic pancreatitis changes in 13.6% and pancreatic atrophy in 31.8% of patients. These results suggest that there is a lack of testing for PEI in ‘at-risk’ groups. Our findings also suggest that using FEL-1 to test for PEI in patients with DM, PLHIV and HAI has a significant impact, although further studies are required to validate these findings.

S6 Treatment of Exocrine Pancreatic Insufficiency in Patients with Chronic/Recurrent Acute Pancreatitis Improves Treatment Satisfaction and Decreases Healthcare Utilization: Interim Findings from the PACT-CP Registry

S6 Treatment of Exocrine Pancreatic Insufficiency in Patients with Chronic/Recurrent Acute Pancreatitis Improves Treatment Satisfaction and Decreases Healthcare Utilization: Interim Findings from the PACT-CP Registry

Dietary therapy for patients with chronic pancreatitis in Japan: a cross-sectional online survey of physicians and registered dietitians.

This study was aimed towards understanding the current status of dietary therapy for patients with pancreatic exocrine insufficiency (PEI) in Japan and its alignment with Japanese recommendations for high-fat intake and concomitant high-potency pancreatic enzyme replacement therapy (PERT) by surveying treating physicians and registered dietitians. The 19-item physicians' online questionnaire collected data about the number of patients with PEI treated, methods used to assess PEI and nutritional status in patients with PEI, as well as provision of dietary guidance and details of treatment with PERT. The 10-item registered dietitians' online questionnaire captured data about the provision of dietary guidance, including setting (inpatient or outpatient) and details of nutritional guidance provided to patients. Overall, 35 physicians and 23 dietitians completed the respective questionnaires. The primary cause of PEI in patients treated by physicians during the previous month was chronic pancreatitis (80.5%). Of 30 (86%) physicians who reported implementing dietary guidance for patients with PEI, less than half (43%) followed national guidelines and most (83%) implemented a low-fat diet. The use of PERT in recently treated patients with PEI was low. Amongst 11 (48%) dietitians who reported providing dietary guidance to patients with chronic pancreatitis and PEI, 7 (64%) recommended restricting fat intake in patients with uncompensated chronic pancreatitis. Dietitians overall were more likely to provide guidance about alcohol avoidance (91%) than smoking cessation (48%) to appropriate patients. This survey suggests that additional educational efforts are required to align the management practices of physicians and registered dietitians with evidence-based clinical practice guidelines for Japanese patients with chronic pancreatitis and PEI.

Exocrine Pancreatic Insufficiency Is Common in Celiac Disease: A Systematic Review and Meta-Analysis.

The prevalence of celiac disease (CD) is approximately 1% in the US. Studies have shown possible association between exocrine pancreatic insufficiency (EPI) and CD, with numerous hypothesized biological mechanisms including small bowel mucosal damage causing disruption of enteric-mediated hormonal secretion such as cholecystokinin and loss of enterokinase. The overall prevalence of EPI in CD remains unknown. We performed systematic review and metanalysis and examined the prevalence of EPI in patients who were first diagnosed with CD versus those who had been on treatment with gluten-free diet (GFD). ResultsSix studies were included in the analysis totaling 446 CD patients (Avg age 44.1years; 34% Males). One hundred and forty-four patients had newly diagnosed CD, and 302 patients had known CD with at least 9months treatment with GFD. Four studies examined newly diagnosed CD patients. The individual rates of EPI in new CD patients ranged from 10.5 to 46.5%. The pooled prevalence of EPI in newly diagnosed CD patients was 26.2% (95% CI 8.43-43.92%, Q = 2.24, I2 = 0%). Five studies examined CD patients on GFD. The rate of EPI ranged from 1.9% to 18.2%. The prevalence of EPI in patients treated with GFD is 8% (95% CI 1.52-14.8%, Q = 4.42, I2 = 9.59%). Patients with newly diagnosed CD are significantly more likely to have EPI compared to those patients treated with GFD (p = 0.031). CD patients on GFD with persistent symptoms have a significantly higher rate of EPI (28.4%) compared to CD patients on GFD who are asymptomatic (3%) (p < 0.001).

Evaluation of the Frequency of Exocrine Pancreatic Insufficiency in Patients With Diabetes Mellitus

Searchable abstracts of presentations at key conferences in endocrinology ISSN 1470-3947 (print) | ISSN 1479-6848 (online)

Prospective Observational Study of Prevalence, Assessment and Treatment of Pancreatic Exocrine Insufficiency in Patients with Inoperable Pancreatic Malignancy (PANcreatic Cancer Dietary Assessment-PanDA).

Pancreatic exocrine insufficiency (PEI) in patients with advanced pancreatic cancer (aPC) is well documented, but there is no consensus regarding optimal screening. Patients diagnosed with aPC referred for palliative therapy were prospectively recruited. A full dietetic assessment (including Mid-Upper Arm Circumference (MUAC), handgrip and stair-climb test), nutritional blood panel, faecal elastase (FE-1) and 13C-mixed triglyceride breath tests were performed. prevalence of dietitian-assessed PEI (demographic cohort (De-ch)); design (diagnostic cohort (Di-ch)) and validation (follow-up cohort (Fol-ch)) of a PEI screening tool. Logistic and Cox regressions were used for statistical analysis. Between 1 July 2018 and 30 October 2020, 112 patients were recruited (50 (De-ch), 25 (Di-ch) and 37 (Fol-ch)). Prevalence of PEI (De-ch) was 64.0% (flatus (84.0%), weight loss (84.0%), abdominal discomfort (50.0%) and steatorrhea (48.0%)). The derived PEI screening panel (Di-ch) included FE-1 (normal/missing (0 points); low (1 point)) and MUAC (normal/missing (>percentile 25) (0 points); low (2 points)) and identified patients at high-risk (2-3 total points) of PEI [vs. low-medium risk (0-1 total points)]. When patients from the De-ch and Di-ch were analysed together, those classified by the screening panel as "high-risk" had shorter overall survival (multivariable Hazard Ratio (mHR) 1.86 (95% CI 1.03-3.36); p-value 0.040). The screening panel was tested in the Fol-ch; 78.4% patients classified as "high-risk", of whom 89.6% had dietitian-confirmed PEI. The panel was feasible for use in clinical practice (64.8% patients completed all assessments), with high acceptability (87.5% would repeat it). Most patients (91.3%) recommended dietetic input for all patients with aPC. PEI is present in most patients with aPC; early dietetic input provides a holistic nutritional overview, including, but not limited to, PEI. This proposed screening panel may help to prioritise those at higher risk of PEI, requiring urgent dietitian input. Its prognostic role needs further validation.

A clinical case of exocrine pancreatic insufficiency in a patient with type 1 diabetes mellitus

The pancreas belongs to the glands of mixed secretion and simultaneously performs both endo- and exocrine functions. Exocrine pancreatic insufficiency (EPI) is the general name for the malabsorption process caused by inadequate production and decreased activation of the enzymes of the pancreas acinar cells, such as amylase, lipase and protease, which are necessary for digestion. The prevalence of EPI in patients with type 1 diabetes, according to many authors, varies from 25 to 59%, which is determine by the data of pancreatic elastase-1. In this work, we present a clinical case of confirmed exocrine pancreatic insufficiency in a patient with a 6-year history of type 1 diabetes, which became the main cause of the development of episodes of hypoglycemia after meals. In the course of further studies, antibodies to lactoferrin and a reduced prostate volume, determined by MRI data, high levels of antibodies to glutamate decarboxylase and zinc co-transporter 8, as well as residual insulin secretion based on the level of C-peptide on an empty stomach detected.

Psychosomatic disorders in chronic pancreatitis

Diagnosis of pancreatic exocrine insufficiency (PEI) is hindered by methodological difficulties of pancreatic function tests. The probability of PEI in chronic pancreatitis (CP) increases as pancreatic fibrosis develops. Pancreatic fibrosis in CP may be quantified by EUS elastography.To evaluate whether EUS-elastography can predict PEI in patients with CP.Prospective, observational study.Department of Gastroenterology, University Hospital of Santiago de Compostela, Spain.Patients diagnosed with CP based on EUS and magnetic resonance imaging and MRCP findings.Diagnosis of PEI was based on the 13C-mixed triglyceride breath test. EUS-elastography was performed with PENTAX echoendoscopes and Hitachi-Preirus US platform. Two areas were selected for elastographic evaluation: area A corresponds to the pancreatic parenchyma and area B to a soft peripancreatic reference area. The quotient B/A (strain ratio [SR]) was considered the elastographic result.Pancreatic SR in CP patients with and without PEI.A total of 115 patients with CP (mean age, 50.2 years, range, 21-81; 92 male) of different etiologies were included; 35 patients (30.4%) had PEI. Pancreatic SR was higher in patients with PEI (4.89; 95% confidence interval, 4.36-5.41) than in those with a normal breath test result (2.99; 95% confidence interval, 2.82-3.16) (P < .001). A direct relationship was found between the SR and the probability of PEI, which increases from 4.2% in patients with an SR less than 2.5 to 92.8% in those with an SR greater than >5.5.Single-center study.The degree of pancreatic fibrosis as measured by EUS-guided elastography allows quantification of the probability of PEI in patients with CP.

Changes of oral and duodenal microbiota in patients with pancreatic cancer are possible diagnostic and prognostic biomarkers

Diagnosis of pancreatic exocrine insufficiency (PEI) is hindered by methodological difficulties of pancreatic function tests. The probability of PEI in chronic pancreatitis (CP) increases as pancreatic fibrosis develops. Pancreatic fibrosis in CP may be quantified by EUS elastography.To evaluate whether EUS-elastography can predict PEI in patients with CP.Prospective, observational study.Department of Gastroenterology, University Hospital of Santiago de Compostela, Spain.Patients diagnosed with CP based on EUS and magnetic resonance imaging and MRCP findings.Diagnosis of PEI was based on the 13C-mixed triglyceride breath test. EUS-elastography was performed with PENTAX echoendoscopes and Hitachi-Preirus US platform. Two areas were selected for elastographic evaluation: area A corresponds to the pancreatic parenchyma and area B to a soft peripancreatic reference area. The quotient B/A (strain ratio [SR]) was considered the elastographic result.Pancreatic SR in CP patients with and without PEI.A total of 115 patients with CP (mean age, 50.2 years, range, 21-81; 92 male) of different etiologies were included; 35 patients (30.4%) had PEI. Pancreatic SR was higher in patients with PEI (4.89; 95% confidence interval, 4.36-5.41) than in those with a normal breath test result (2.99; 95% confidence interval, 2.82-3.16) (P < .001). A direct relationship was found between the SR and the probability of PEI, which increases from 4.2% in patients with an SR less than 2.5 to 92.8% in those with an SR greater than >5.5.Single-center study.The degree of pancreatic fibrosis as measured by EUS-guided elastography allows quantification of the probability of PEI in patients with CP.

A Retrospective Real-World Evidence Evaluation of the Characteristics of Exocrine Pancreatic Insufficiency in Patients With Chronic Pancreatitis and Type 2 Diabetes Treated With Pancrelipase in the United States.

This retrospective real-world data analysis assessed clinical/health care professional characteristics of gastrointestinal symptom profiles in pancrelipase-treated patients with exocrine pancreatic insufficiency symptoms and chronic pancreatitis (CP) or type 2 diabetes (T2D). Data were from the Decision Resources Group Real-World Evidence Data Repository US database. Patients 18 years and older receiving pancrelipase (Zenpep) between index dates August 2015 and June 2020 were included. Gastrointestinal symptoms were assessed 6, 12, and 18 months post-index versus baseline. A total of 10,656 pancrelipase-treated patients with CP (n = 3215) or T2D (n = 7441) were identified. Significant/sustained reductions in gastrointestinal symptoms were observed in both cohorts after pancrelipase treatment (P < 0.001) versus baseline. Significantly fewer patients with CP compliant with treatment for more than 270 days (n = 1553) reported abdominal pain (P < 0.001) and nausea/vomiting (P < 0.05) versus those compliant for less than 90 days (n = 1115). Significantly fewer patients with T2D compliant with treatment for more than 270 days (n = 2964) reported abdominal pain (P < 0.001) and diarrhea/steatorrhea (P < 0.05) versus those compliant for less than 90 days (n = 2959). Pancrelipase reduced exocrine pancreatic insufficiency symptoms in patients with CP or T2D, with greater treatment compliance associated with improved gastrointestinal symptom profiles.

S9 Development of a Clinical Screening Tool for Exocrine Pancreatic Insufficiency in Patients With Chronic Pancreatitis

Introduction: No accurate diagnostic tests exist for exocrine pancreatic insufficiency (EPI). As a result, EPI is misdiagnosed, including in chronic pancreatitis (CP), and there is an unmet need for clinical tools to help clinicians evaluate patients with CP at risk for EPI. The aim of this study was to generate a simple clinical tool to predict EPI in patients with CP. Methods: 49 variables from medical records of CP patients with or without EPI were entered into a Classification and Regression Tree (CART) model using the unimputed full analysis set and 4 other models (Logistic Regression with Least Absolute Shrinkage and Selection Operator regularization, Support Vector Machine, Random Forest, and Gradient Boosting Machine) using imputed full analysis set. EPI misclassification rate (mRate) served as primary metric to train the 5 prediction models. Each model’s generalizability was assessed using 5-fold cross-validation and the model that was best suited for clinician use based on mRate and other characteristics was selected. Results: Records of 274 patients with CP from 6 pancreatitis centers across the US were included. Among the 160 (58%)/114 (42%) patients with EPI/without EPI, 48%/55% were female, mean age was 55/52 years, 76%/69% were white, 29%/52% were never smokers, and 39%/53% were never alcohol users. All 5 prediction models demonstrated similar EPI mRates. The CART model was selected. The final CART decision tree includes 10 variables (in order of importance): smoking, pancreatic atrophy, steatorrhea, alcohol use, hemoglobin, serum vitamin D, pancreatic duct contour change, serum albumin, pancreatic parenchymal calcifications, and use of opioid analgesics. The mRate without and with 5-fold cross-validation of the CART was 0.153 (training error) and 0.314 (prediction error), and the area under the receiver operating characteristic curve was 0.889 and 0.682, respectively (Figure 1). Sensitivity/specificity without/with 5-fold cross validation was 0.888/0.789 and 0.794/0.535, respectively. Conclusion: A parsimonious set of 10 variables associated with EPI in CP was identified. The CART decision tree demonstrated good prediction performance for EPI and was selected as the most practical screening tool to aid clinicians in the assessment of EPI in patients with CP. Further external validation of the EPI screening tool is planned.Figure 1.: AUC-ROC of the CART model trained on the full analysis set and after 5-fold cross-validation. AUC, area under the curve; CART, classification and regression tree; CV, cross-validation; ROC, receiver operating characteristic.

Abbreviated 13C-mixed triglyceride breath test for detection of pancreatic exocrine insufficiency performs equally as standard 5-hour test in patients after gastrectomy performed for gastric cancer.

Background13C-mixed triglyceride breath test (13C-MTGT) is a non-invasive test for the detection of moderate and severe pancreatic exocrine insufficiency (PEI), but it requires prolonged breath sampling. The aim of this study was to determine the diagnostic power of abbreviated 13C-MTGT in detecting PEI in patients after subtotal and total gastrectomy performed due to gastric cancer.Subjects and methodsThis cross-sectional observational study included 3 groups of subjects; healthy controls, patients with subtotal and patients with total gastrectomy. Demographic and clinical data of patients were collected. Stool samples to determine faecal elastase (Fe-1) and chymotrypsin were collected and measured by ELISA. All subjects performed 5-hour 13C-MTGT breath test. The concentration and relative content of 13C in exhaled air was measured by isotope ratio mass spectrometer (IRMS). PEI was confirmed as values of 13C-exhalation < 26.8% after 5 hours.ResultsOverall, 65 participants were included into analysis, 22 having PEI (n = 11 after subtotal and n = 11 after total gastrectomy, both performed for gastric cancer). 13C-MTGT breath test showed difference in percent of exhaled 13C between PEI and non-PEI patients already after 60 minutes (p = 0.034). Receiver operating characteristic (ROC) curve analysis showed that cut-off value of 13.74% after 150 minutes is showing equivalent diagnostic power to the longer test with sensitivity and specificity both above 90% for the exclusion of PEI in patients after subtotal and/or total gastrectomy.ConclusionsIn this study abbreviated 13C-MTGT test could be shortened from 5 to 2.5 hours without decrease in its diagnostic accuracy for detection of PEI in patients with subtotal or total gastrectomy performed for gastric cancer. This allows significant time savings in the diagnostics of PEI in this subgroup of patients.