Use of pancreatic endotherapy in patients with chronic pancreatitis: results from a multicenter cohort study in the United States.

BACKGROUND AND AIMS: Although pancreatic endotherapy (PET) is commonly used for treating adverse events of chronic pancreatitis, data on the frequency and factors associated with the use of PET are limited. Our aim was to define the use of and factors predictive for receiving PET in a well-characterized chronic pancreatitis cohort. METHODS: This is a cross-sectional analysis of data from PROCEED, a multicenter U.S. cohort study of chronic pancreatitis. PET modalities primarily consisted of ERCP. A treatment course was defined as the number of sessions performed for a specific indication. A repeat course was defined as PET >1 year after completion of the last course. Multivariable logistic regression identified predictive factors for receiving PET, and proportional rates model assessed risk factors for repeat PET. RESULTS: Of 681 subjects, 238 (34.9%) received PET. Factors associated with receiving PET included female sex (odds ratio [OR], 1.26; 95% confidence interval [CI], 1.03-1.53), lower education (OR, 1.30; 95% CI, 1.04-1.62), income ≤$50,000 per year (OR, 1.35; 95% CI, 1.07-1.71), and prior acute pancreatitis (OR, 1.74; 95% CI, 1.31-2.32). Of 238 subjects, 103 (43.3%) underwent repeat PET at a median duration of 2 years, with 23.1% receiving 2 courses, 9.7% receiving 3 courses, and 10.4% receiving ≥4 courses. CONCLUSIONS: Nearly half of patients with chronic pancreatitis who undergo PET received 1 or more repeat courses within 2 to 3 years. In addition to a prior history of acute pancreatitis, demographic and socioeconomic factors were associated with receiving PET.

AGA Clinical Practice Update on the Epidemiology, Evaluation, and Management of Exocrine Pancreatic Insufficiency: Expert Review.

DESCRIPTION: Exocrine pancreatic insufficiency (EPI) is a disorder caused by the failure of the pancreas to deliver a minimum/threshold level of specific pancreatic digestive enzymes to the intestine, leading to the maldigestion of nutrients and macronutrients, resulting in their variable deficiencies. EPI is frequently underdiagnosed and, as a result, patients are often not treated appropriately. There is an urgent need to increase awareness of and treatment for this condition. The aim of this American Gastroenterological Association (AGA) Clinical Practice Update Expert Review was to provide Best Practice Advice on the epidemiology, evaluation, and management of EPI. METHODS: This Expert Review was commissioned and approved by the American Gastroenterological Association (AGA) Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership, and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. These Best Practice Advice statements were drawn from a review of the published literature and from expert opinion. Because systematic reviews were not performed, these Best Practice Advice statements do not carry formal ratings regarding the quality of evidence or strength of the presented considerations. Best Practice Advice Statements BEST PRACTICE ADVICE 1: EPI should be suspected in patients with high-risk clinical conditions, such as chronic pancreatitis, relapsing acute pancreatitis, pancreatic ductal adenocarcinoma, cystic fibrosis, and previous pancreatic surgery. BEST PRACTICE ADVICE 2: EPI should be considered in patients with moderate-risk clinical conditions, such as duodenal diseases, including celiac and Crohn's disease; previous intestinal surgery; longstanding diabetes mellitus; and hypersecretory states (eg, Zollinger-Ellison syndrome). BEST PRACTICE ADVICE 3: Clinical features of EPI include steatorrhea with or without diarrhea, weight loss, bloating, excessive flatulence, fat-soluble vitamin deficiencies, and protein-calorie malnutrition. BEST PRACTICE ADVICE 4: Fecal elastase test is the most appropriate initial test and must be performed on a semi-solid or solid stool specimen. A fecal elastase level <100 µg/g of stool provides good evidence of EPI, and levels of 100-200 µg/g are indeterminate for EPI. BEST PRACTICE ADVICE 5: Fecal elastase testing can be performed while on pancreatic enzyme replacement therapy. BEST PRACTICE ADVICE 6: Fecal fat testing is rarely needed and must be performed when on a high-fat diet. Quantitative testing is generally not practical for routine clinical use. BEST PRACTICE ADVICE 7: Response to a therapeutic trial of pancreatic enzymes is unreliable for EPI diagnosis. BEST PRACTICE ADVICE 8: Cross-sectional imaging methods (computed tomography scan, magnetic resonance imaging, and endoscopic ultrasound) cannot identify EPI, although they play an important role in the diagnosis of benign and malignant pancreatic disease. BEST PRACTICE ADVICE 9: Breath tests and direct pancreatic function tests hold promise, but are not widely available in the United States. BEST PRACTICE ADVICE 10: Once EPI is diagnosed, treatment with pancreatic enzyme replacement therapy (PERT) is required. If EPI is left untreated, it will result in complications related to fat malabsorption and malnutrition, having a negative impact on quality of life. BEST PRACTICE ADVICE 11: PERT formulations are all derived from porcine sources and are equally effective at equivalent doses. There is a need for H2 or proton pump inhibitor therapy with non-enteric-coated preparations. BEST PRACTICE ADVICE 12: PERT should be taken during the meal, with the initial treatment of at least 40,000 USP units of lipase during each meal in adults and one-half of that with snacks. The subsequent dosage can be adjusted based on the meal size and fat content. BEST PRACTICE ADVICE 13: Routine supplementation and monitoring of fat-soluble vitamin levels are appropriate. Dietary modifications include a low-moderate fat diet with frequent smaller meals and avoiding very-low-fat diets. BEST PRACTICE ADVICE 14: Measures of successful treatment with PERT include reduction in steatorrhea and associated gastrointestinal symptoms; a gain of weight, muscle mass, and muscle function; and improvement in fat-soluble vitamin levels. BEST PRACTICE ADVICE 15: EPI should be monitored and baseline measurements of nutritional status should be obtained (body mass index, quality-of-life measure, and fat-soluble vitamin levels). A baseline dual-energy x-ray absorptiometry scan should be obtained and repeated every 1-2 years.

Impact of Biopsy Attempts, Race, and Access on Time to Initiation of Treatment for Pancreatic Cancer.

BACKGROUND: Biopsy of suspected pancreatic cancer (PDAC) in surgical candidates is informative however not always necessary. Biopsies impact treatment options as histological diagnosis are presently required for neo-adjuvant therapy, but not surgical resection. We explored the impact of pursuing tissue diagnosis by endoscopic ultrasound (EUS) biopsy on time to treatment in patients with resectable and borderline resectable PDAC. METHODS: A retrospective review of surgical patients with ultimately proven PDAC was performed (2011-2021). Milestone dates (cancer suspected, biopsy(ies), surgical or neo-adjuvant treatment) were collected. Mann-Whitney-Wilcoxon tests, Pearson's chi-squared tests, Fisher's exact tests, linear regressions, and Cox proportional hazard models were used for data analysis. RESULTS: Among 131 resectable and 58 borderline resectable patients, the borderline resectable group underwent more biopsies (1.2 vs 0.7, p < 0.0001), were more likely to undergo biopsy at tertiary care centers (67.2% vs 30.5%, p < 0.0001), and trended toward longer time to treatment (49 vs 44 days, p = 0.070). Significant increases in days to treatment were seen in patients with Black race (29 days, p = 0.0002) and Medicare insurance (22 days, p = 0.038) and no biopsies at a tertiary care center (10 days, p = 0.039). After adjusting for covariates, additional biopsies significantly delayed treatment (1 biopsy: 21 days, p = 0.0001; 2 biopsies: 44 days, p < 0.0001; 3 biopsies: 68 days, p < 0.0001). CONCLUSIONS: EUS biopsy significantly impacts time between suspicion and treatment of PDAC. This may be exacerbated by clinical practices increasingly favoring neo-adjuvant therapy that necessitates biopsy-proven disease. Time to treatment may also be impacted by access to tertiary centers and racial disparities.

Period prevalence of chronic pancreatitis diagnosis from 2001-2013 in the commercially insured population of the United States.

BACKGROUND: Prevalence estimates of chronic pancreatitis (CP) in the US are scarce. We aimed to determine the prevalence of CP in the commercially insured population of the US. METHODS: We analyzed the IQVIA Legacy PharMetrics database to calculate the period prevalence of CP from 2001 to 2013 among individuals with ≥1 year of enrollment. CP was defined as ≥1 healthcare contacts associated with a non-ancillary claim for a primary diagnosis of CP (ICD-9-CM 577.1). Prevalence estimates were age- and sex- adjusted to the 2010 US population. Sensitivity analysis was performed by using more stringent criteria: a) 1 claim of CP + [≥1 claims of acute pancreatitis (AP), CP or pancreatic cyst/pseudocyst]; b) 1 claim of CP + [≥1 claims for AP, CP or pancreatic cyst/pseudocyst in ≥3 months before or after the index CP claim]; c) ≥2 claims for CP; and d) ≥2 claims for CP separated by ≥ 6 months. RESULTS: Of 48.67 million eligible enrollees, 37,061 received the diagnosis of CP (mean age, 51.2 ±â€¯15.2 years; 49% male). The age- and sex- adjusted period prevalence of CP per 100,000 was 73.4 (95% CI, 72.6-74.1), 98.7 (95% CI, 97.7-99.7) for adults and 8.3 (95% CI, 7.8-8.8) for children. Prevalence of CP was slightly higher in males (sex ratio, 1.05) and highest in the age group of 46-55 years (135/100,000). On sensitivity analysis, the prevalence of CP per 100,000 decreased to 60.2, 39.7, 38.8, and 18.8 with each of the alternative definitions. CONCLUSION: Prevalence estimates reported in our study provide an insight into the population burden of CP in the US.

The difficulty in predicting outcome in acute pancreatitis.

Current methods to predict the development of severe pancreatitis are complex, cumbersome, and inaccurate. Simpler scoring systems like the one studied in this issue of the Journal are an improvement in simplicity but not in accuracy. More sophisticated approaches are needed for more accurate prediction, which would allow improved triage and management of these patients.

Comparative analysis of direct pancreatic function testing versus morphological assessment by endoscopic ultrasonography for the evaluation of chronic unexplained abdominal pain of presumed pancreatic origin.

OBJECTIVES: The diagnosis of "minimal change" chronic pancreatitis (MCCP) is often considered when conventional imaging studies are unrevealing in a patient population with abdominal pain of presumed pancreatic origin. Direct pancreatic function testing using secretin as a secretagogue (ST) has been considered the most sensitive method to diagnose MCCP but is not widely available to clinicians. Endoscopic ultrasound (EUS) allows detailed imaging of pancreatic architecture, but the sensitivity and specificity for MCCP remain to be determined. We sought to compare the accuracy of EUS and ST in patients with presumed MCCP. METHODS: Seventy-four patients referred to our pancreas clinic with unexplained abdominal pain and previously negative imaging studies underwent an ST for evaluation of possible MCCP. Twenty-one of these also underwent EUS. EUS images were read by 1 of 2 experts blinded to ST results. RESULTS: Using ST as the "gold standard," EUS had a maximum sensitivity of 71% when the cut-off for diagnosis was set at at least 3 EUS features. Conversely, maximum specificity (92%) was seen when the cut-off value was set at at least 6 EUS criteria. Diagnostic certainty was only 50% (positive predictive value = 0.5) when at least 6 criteria were used as the cut-off. MCCP was excluded with greater than 70% certainty when less than 3 criteria were present. At the best cut-off value of at least 4 features, EUS had a sensitivity of 57% and a specificity of 64%. CONCLUSIONS: In this patient population with abdominal pain of presumed pancreatic origin, EUS and standard pancreatic function testing are often discordant. If ST is assumed to be the reference against which other tests are compared, EUS is less accurate than ST in diagnosing MCCP.