Pancreas units within gastroenterology departments. Organizational and operational standards for a patient-centered service.

The Asociación Española de Pancreatología (AESPANC), Asociación Española de Gastroenterología (AEG), and Sociedad Española de Patología Digestiva (SEPD) have developed a consensus document on the standards and recommendations they consider essential for the organization of pancreas units (PUs) within gastroenterology services (GSs) in order to conduct their activities in an efficient, high-quality manner. The consensus document defines PUs and lays down standards relating to their organization, structure, service portfolio, processes, and teaching and research activities. Standards have been categorized as mandatory (requirements to be met to qualify for certification by the scientific societies responsible for the standards) or recommendations. Standards should be updated at most within five years based on the experience gained in Spanish PUs and the advance of knowledge regarding pancreas disease. Development of health outcome indicators, including patient-reported outcome measures (PROMs), is considered a relevant challenge, as is evidence on the association of PU structure and activity standards with health outcomes.

Pancreas units within gastroenterology departments. Organizational and operational standards for a patient-centered service. / Las unidades de páncreas en los servicios de aparato digestivo. Estándares de organización y funcionamiento para un servicio centrado en el paciente.

The Asociación Española de Pancreatología (AESPANC), Asociación Española de Gastroenterología (AEG), and Sociedad Española de Patología Digestiva (SEPD) have developed a consensus document on the standards and recommendations they consider essential for the organization of pancreas units (PUs) within gastroenterology services (GSs) in order to conduct their activities in an efficient, high-quality manner. The consensus document defines PUs and lays down standards relating to their organization, structure, service portfolio, processes, and teaching and research activities. Standards have been categorized as mandatory (requirements to be met to qualify for certification by the scientific societies responsible for the standards) or recommendations. Standards should be updated at most within five years based on the experience gained in Spanish PUs and the advance of knowledge regarding pancreas disease. Development of health outcome indicators, including patient-reported outcome measures (PROMs), is considered a relevant challenge, as is evidence on the association of PU structure and activity standards with health outcomes.

Development of a new risk score for invasive cancer in branch-duct intraductal papillary mucinous neoplasms according to morphological characterization by EUS.

BACKGROUND AND OBJECTIVE: The management of branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs) is determined by a number of guidelines. The current weight of risk factors by EUS predicting invasive cancer is unknown. The aim of this study is to develop a risk score for early prediction of invasive cancer according to morphological characterization by EUS in a surgical cohort. MATERIALS AND METHODS: This is an observational, multicenter retrospective study. All consecutive patients with a histologically proven BD-IPMN who underwent previous EUS between 2005 and 2017 were included. Morphological features by EUS were evaluated. A score using a logistic regression model was performed to assess the risk of invasive cancer. RESULTS: Of 335 patients who underwent pancreatic surgery, 131 (median age: 66 years, 50.4% - male) were included. By multivariable analysis, lymph nodes (odds ratio [OR]: 17.7 [confidence interval (CI) 95%: 2.8-112.6], P = 0.002, 4 points), main pancreatic duct ≥10 mm (OR: 8.6 [CI 95%: 1.9-39.5], P = 0.006, 2 points), abrupt change of pancreatic duct (OR: 5.5 [CI 95%: 1.4-22.2], P = 0.016, 1.5 points), and solid component (OR: 4.2 [CI 95%: 1.3-13.6], P = 0.017, 1 point) were independent factors associated with invasive cancer and included in the model. The following categories of the score (0-8.5 points) - A (0-1), B (1.5-3), C (3.5-5), and D (5.5-8.5 points) - presented a positive predictive value of 8.5%, 38.9%, 62.5%, and 100%, respectively. The area under the curve was 0.857 (P < 0.001), with an overall sensitivity and specificity of 84% and 70% in the internal validation of the score. CONCLUSION: This EUS predictive score for invasive cancer in BD-IPMN has a high accuracy and could be an additional tool to consider in patient management.

Statin consumption and risk of post-endoscopic retrograde cholangiopancreatography pancreatitis.

BACKGROUND: The most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP) is post-ERCP acute pancreatitis (PEP). Statin consumption seems to lower the incidence of acute pancreatitis. We aimed to investigate the relationship between the use of statins and the incidence of PEP. METHODS: multicenter (4 Spanish tertiary-level public hospitals) retrospective cohort study. Adult patients undergoing an ERCP were included in the study. We excluded patients with chronic pancreatitis, with ongoing acute pancreatitis and those who developed other complications after ERCP. Patients were classified into 2 groups: those under statin treatment (group S) and controls (group C). A multivariate analysis was performed (binary logistic regression) including age, center, female gender, previous pancreatitis, suspected sphincter of Oddi dysfunction, difficult cannulation (>10 min), >1 pancreatic guidewire passages, pancreatic injection, pancreatic stenting and presence of choledocholitiasis. RESULTS: seven hundred and two patients were included, median age 74 (62-82 years), 330 (47%) females, 223 (32%) in group S. Thirty-five (5%) patients developed PEP, 6 (3%) in group S and 29 (6%) in group C. Statin use was not associated with a lower frequency of PEP in univariate analysis, OR 0.429 (95% confidence interval 0.176-1.05, p = 0.06) or in multivariate analysis, adjusted OR 0.5 (0.19-1.32), p = 0.16. Statin use had no effect on severity of PEP, being mild in 50% vs 78.6% in non-statin users, p = 0.306. CONCLUSIONS: the chronic use of statins was not associated with a decreased risk of PEP or a milder course of disease in our sample of patients.

CA19-9 capability as predictor of pancreatic cancer resectability in a Spanish cohort.

CA19-9 serum has been suggested as a marker of unresectability but different cut-off levels have been published. A cut-off of 500 U/ml is currently considered in an international consensus as biological criteria of borderline resectable pancreatic adenocarcinoma. To evaluate whether serum CA19-9 threshold of 500 U/ml could be adequate predictor of resectability in pancreatic adenocarcinoma. Multicenter, observational, prospective study performed in Spain including 203 patients diagnosed with pancreatic adenocarcinoma. 43 (21.2%) cases were resectable and 160 (78.8%) unresectable. Among the 176 preoperative CA19-9 available values, 98 (58.3%) were ≤ 500 U/ml and 73 (42.7%) > 500 U/ml. Resectability rate in those patients with CA19-9 ≤ 500 U/ml was 60% while it was found to be 18% when CA19-9 > 500 U/ml. Statistical model to predict resectability based on CA19-9 provide an AUC of 0.6618 (95% CI 0.53-0.83) when only CA19-9 values > 500 U/ml are studied. Serum levels of CA19-9 higher than 500 U/ml are indicative of unresectable disease, however reduced sensitivity and specificity lead to a limited clinical applicability for resectability.

Hemostatic spray powder TC-325 for GI bleeding in a nationwide study: survival and predictors of failure via competing risks analysis.

BACKGROUND AND AIMS: TC-325 (Hemospray, Cook Medical, Winston-Salem, NC) is an inorganic hemostatic powder recently approved by the U.S. Food and Drug Administration. This study aimed to examine the effectiveness, safety, and predictors of TC-325 failure in a large real-life cohort. METHODS: This was a retrospective study conducted at 21 Spanish centers. All patients treated with TC-325 until September 2018 were included. The primary outcome was treatment failure, defined as failed intraprocedural hemostasis or recurrent bleeding within the first 30 postprocedural days. Secondary outcomes included safety and survival. Risk and predictors of failure were assessed via competing-risk models. RESULTS: The cohort comprised 261 patients, of whom 219 (83.9%) presented with upper gastrointestinal bleeding (GIB). The most common causes were peptic ulcer (28%), malignancy (18.4%), and therapeutic endoscopy-related GIB (17.6%). TC-325 was used as rescue therapy in 191 (73.2%) patients. The rate of intraprocedural hemostasis was 93.5% (95% confidence interval [CI], 90%-96%). Risks of TC-325 failure at postprocedural days 3, 7, and 30 were 21.1%, 24.6%, and 27.4%, respectively. On multivariate analysis, spurting bleeding (P = .004), use of vasoactive drugs (P = .02), and hypotension (P = .008) were independent predictors of failure. Overall 30-day survival was 81.9% (95% CI, 76%-86%) and intraprocedural hemostasis was associated with a better prognosis (adjusted hazard ratio, 0.29; P = .006). Two severe adverse events were noted. CONCLUSION: TC-325 was safe and effective for intraprocedural hemostasis in more than 90% of patients, regardless of the cause or site of bleeding and its use as rescue therapy. In this high-risk cohort treated with TC-325, the 30-day failure rate exceeded 25% and was highest with spurting bleeding or hemodynamic instability.

Influence of age, body mass index and comorbidity on major outcomes in acute pancreatitis, a prospective nation-wide multicentre study.

BACKGROUND: There are few large prospective cohort studies evaluating predictors of outcomes in acute pancreatitis. OBJECTIVES: The purpose of this study was to determine the role of age and co-morbid disease in predicting major outcomes in acute pancreatitis. METHODS: Data points were collected according to a predefined electronic data collection form. Acute pancreatitis and its complications were defined according to the revised Atlanta classification. Univariable and multivariable analyses were conducted using Cox proportional hazard regression and multiple logistic regression. RESULTS: From June 2013-February 2015, 1655 adult patients were recruited from 23 centres across Spain. Co-morbid disease, obesity, open surgical necrosectomy within 30 days, and pancreatic necrosis were independently associated with both 30-day mortality and persistent organ failure (p < 0.05 for all). Age was not associated with persistent organ failure, however the extreme of age (>85 years) was associated with mortality (p < 0.05). Co-morbid disease and obesity were not independently associated with a prolonged length of stay or other markers of morbidity on adjusted analysis (p > 0.05). CONCLUSION: Comorbidity and obesity are important determinates of mortality and persistent organ failure in acute pancreatitis, but in the absence of organ failure they do not appear to independently contribute to morbidity. This has important implications for severity classification and predictive models of severity in acute pancreatitis.

Vitamins D and K as Factors Associated with Osteopathy in Chronic Pancreatitis: A Prospective Multicentre Study (P-BONE Study).

BACKGROUND: Osteopathy is common in patients with chronic pancreatitis (CP), but previous studies carry several limitations. Vitamin K is essential for bone metabolism, but its role in this setting has never been investigated. Our aim is to assess the prevalence of osteoporosis and osteopenia in CP patients, and to investigate the association between osteopathy and CP features and nutritional parameters, especially vitamin D and K levels. METHODS: Multicentre cross-sectional study on CP patients diagnosed according to M-ANNHEIM criteria. Bone density was evaluated by dual-energy X-ray absorptiometry and pancreatic function by faecal elastase. Nutritional evaluation included vitamin D and vitamin K. Differences between patients with or without osteopathy were evaluated. The association between investigated variables and bone density were analysed with logistic regression analysis. RESULTS: In total, 211 CP patients were enrolled at eight Centres (67% men; mean age 60). In total, 18% had advanced-marked CP, 56% suffered from pancreatic exocrine insufficiency and disease aetiology was alcoholic in 43%. Vitamin D and K were deficient in 56% and 32%, respectively. Osteopenia was diagnosed in 42% and osteoporosis in 22%. In the multivariate analysis, female sex (OR 2.78), age (OR 1.07 per year) and higher BMI (OR 0.84) were associated with the presence of osteoporosis. In male patients, the only factor associated with osteoporosis was vitamin K deficiency (OR 4.23). CONCLUSION: The present data confirm a high rate of osteopathy in CP patients and highlight the relevance of vitamin K deficiency as only factor associated with osteoporosis in male patients for the first time.

Prevalence of exocrine pancreatic insufficiency in patients with chronic pancreatitis without follow-up. PANCR-EVOL Study / Prevalencia de insuficiencia pancreática exocrina en pacientes con pancreatitis crónica sin segruimiento. Estudio PANCR-EVOL

Background/objectives. Exocrine pancreatic insufficiency (EPI) is an important complication of chronic pancreatitis (CP). Guidelines recommend to rule out EPI in CP, to detect those patients who would benefit from pancreatic enzyme replacement therapy. The aim of this study was to evaluate the prevalence of EPI in patients with CP without follow-up in the last 2 years and to describe their nutritional status and quality of life (QoL). Methods. This was a cross-sectional, multicenter Spanish study. CP patients without follow-up by a gastroenterologist or surgeon in at least 2 years were included. EPI was defined as fecal elastase test <200mcg/g. For nutritional assessment, laboratory and anthropometric data were obtained. QoL was investigated using the EORTC QLQ-C30 questionnaire. Results. 64 patients (mean age 58.8±10.3 years, 85.9% men) from 10 centers were included. Median time since diagnosis of CP was 58.7 months [37.7-95.4]. Forty-one patients (64.1%) had EPI. Regarding nutritional status, the following differences were observed (EPI vs. Non-EPI): BMI (23.9±3.5kg/m2 vs. 25.7±2.5, p=0.03); glucose (121 [96-189] mg/dL vs. 98 [90-116], p=0.006); HbA1c 6.6% [6.0-8.4] vs. 5.5 [5.3-6.0], p=0.0005); Vitamin A (0.44mg/L [0.35-0.57] vs. 0.53 [0.47-0.63], p=0.048) and Vitamin E (11.2±5.0μg/ml vs. 14.4±4.3, p=0.03). EPI group showed a worse EORTC QLQ-C30 score on physical (93.3 [66.7-100] vs. 100 [93.3-100], p=0.048) and cognitive function (100 [83.3-100] vs. 100 [100-100], p=0.04). Conclusions. Prevalence of EPI is high in patients with CP without follow-up. EPI group had higher levels of glucose, lower levels of vitamins A and E and worse QoL (AU)

Antecedentes/objetivos. la insuficiencia pancreática exocrina (IPE) es una importante complicación de la pancreatitis crónica (PC). Las guías recomiendan el seguimiento de la IPE en PC, para identificar a aquellos pacientes que puedan beneficiarse del tratamiento enzimático sustitutivo. El objetivo de este estudio fue evaluar la prevalencia de IPE en pacientes con PC sin seguimiento en los últimos 2 años y describir su estado nutricional y calidad de vida (QoL). Métodos. estudio trasversal, multicéntrico, español. Se incluyeron pacientes con PC sin seguimiento por un gastroenterólogo/cirujano en los últimos 2años. Se definió IPE como elastasa fecal<200mcg/g. Se recogieron parámetros de laboratorio y datos antropométricos para el análisis nutricional. Para la evaluación de QoL se utilizó el cuestionario EORTC QLQ-C30. Resultados. se incluyeron prospectivamente 64 pacientes (58,8±10,3 años, media 85,9%) de 10 centros. Tiempo medio desde el diagnóstico de PC: 58,7meses [37,7-95,4]. 41 pacientes (64,1%) tenían IPE. Estado nutricional: se observaron las siguientes diferencias (IPE vs No-IPE): IMC (23,9±3,5kg/m2 vs. 25,7±2,5,p=0,03); glucosa 121 [96-189] mg/dL vs. 98 [90-116];p =0,006); HbA1c 6,6% [6,0-8,4] vs. 5,5 [5,3-6,0],p=0,0005); Vitamina-A (0,44mg/L [0,35-0,57] vs. 0,53 [0,47-0,63],p=0,048), Vitamina-E (11,2±5,0μg/ml vs. 14,4±4,3,p=0,03). El grupo de IPE mostró una peor puntuación en el EORTC QLQ-C30 en las funciones física (93,3 [66,7-100] vs. 100 [93,3-100], p=0,048) y cognitiva (100 [83,3-100] vs. 100 [100-100],p=0,04). Conclusiones. la prevalencia de IPE en pacientes con PC sin seguimiento es elevada. En el grupo de IPE se observaron niveles elevados de glucosa, bajos de vitaminas A y E y peor calidad de vida (AU)

Prevalence of exocrine pancreatic insufficiency in patients with chronic pancreatitis without follow-up. PANCR-EVOL Study.

BACKGROUND/OBJECTIVES: Exocrine pancreatic insufficiency (EPI) is an important complication of chronic pancreatitis (CP). Guidelines recommend to rule out EPI in CP, to detect those patients who would benefit from pancreatic enzyme replacement therapy. The aim of this study was to evaluate the prevalence of EPI in patients with CP without follow-up in the last 2 years and to describe their nutritional status and quality of life (QoL). METHODS: This was a cross-sectional, multicenter Spanish study. CP patients without follow-up by a gastroenterologist or surgeon in at least 2 years were included. EPI was defined as fecal elastase test <200mcg/g. For nutritional assessment, laboratory and anthropometric data were obtained. QoL was investigated using the EORTC QLQ-C30 questionnaire. RESULTS: 64 patients (mean age 58.8±10.3 years, 85.9% men) from 10 centers were included. Median time since diagnosis of CP was 58.7 months [37.7-95.4]. Forty-one patients (64.1%) had EPI. Regarding nutritional status, the following differences were observed (EPI vs. Non-EPI): BMI (23.9±3.5kg/m2 vs. 25.7±2.5, p=0.03); glucose (121 [96-189] mg/dL vs. 98 [90-116], p=0.006); HbA1c 6.6% [6.0-8.4] vs. 5.5 [5.3-6.0], p=0.0005); Vitamin A (0.44mg/L [0.35-0.57] vs. 0.53 [0.47-0.63], p=0.048) and Vitamin E (11.2±5.0µg/ml vs. 14.4±4.3, p=0.03). EPI group showed a worse EORTC QLQ-C30 score on physical (93.3 [66.7-100] vs. 100 [93.3-100], p=0.048) and cognitive function (100 [83.3-100] vs. 100 [100-100], p=0.04). CONCLUSIONS: Prevalence of EPI is high in patients with CP without follow-up. EPI group had higher levels of glucose, lower levels of vitamins A and E and worse QoL.

Prognosis of sporadic resected small (≤2 cm) nonfunctional pancreatic neuroendocrine tumors - a multi-institutional study.

BACKGROUND: Malignant potential of small (≤20 mm) nonfunctional pancreatic neuroendocrine tumors (sNF-PNET) is difficult to predict and management remain controversial. The aim of this study was to assess the prognosis of sporadic nonmetastatic sNF-PNETs. METHODS: Patients were identified from databases of 16 centers. Outcomes and risk factors for recurrence were identified by uni- and multivariate analyses. RESULTS: sNF-PNET was resected in 210 patients, and 66% (n = 138) were asymptomatic. Median age was 60 years, median tumor size was 15 mm, parenchyma-sparing surgery was performed in 42%. Postoperative mortality was 0.5% (n = 1), severe morbidity rate was 14.3% (n = 30), and 14 of 132 patients (10.6%) with harvested lymph nodes had metastatic lymph nodes. Tumor size, presence of biliary or pancreatic duct dilatation, and WHO grade 2-3 were independently associated with recurrence. Patients with tumors sized ≤10 mm were disease free at last follow-up. The 1-, 3- and 5-year disease-free survival rates for patients with tumors sized 11-20 mm on preoperative imaging were 95.1%, 91.0%, and 87.3%, respectively. CONCLUSIONS: In sNF-PNETs, the presence of biliary or pancreatic duct dilatation or WHO grade 2-3 advocate for surgical treatment. In the remaining patients, a wait-and-see policy might be considered.

Deficiency of fat-soluble vitamins in chronic pancreatitis: A systematic review and meta-analysis.

BACKGROUND AND AIMS: Chronic pancreatitis (CP) patients are at risk for fat-soluble vitamins (A, D, E, K) deficiency, but available studies are small and heterogeneous. We conducted a systematic review and meta-analysis to determine the prevalence of fat-soluble vitamins deficiency in CP patients. METHODS: Medline was searched up to January 2016 for case series and case-control studies reporting prevalence of fat-soluble vitamin deficiency in CP patients. The prevalent deficiency rate was pooled for included studies, and deficiency rate between CP and controls, with relative odds ratio (OR) and 95% confidence interval (CI) calculated for case-control studies. RESULTS: Twelve studies including 548 patients included. With a random-effect model, the pooled prevalence rate of vitamin A, D and E deficiency were 16.8% (95%CI 6.9-35.7), 57.6% (95%CI 43.9-70.4) and 29.2% (95%CI 8.6-64.5) respectively, with considerable heterogeneity (I2 = 75%, 87.1% and 92%). Only one study evaluated vitamin K deficiency. The pooled OR for vitamin D deficiency in CP cases compared with controls was 1.17 (95% CI 0.77-1.78). Sensitivity analyses showed lower prevalence of vitamin A and E, and higher prevalence of vitamin D deficiency in high-quality studies. The rate of pancreatic exocrine insufficiency did not seem affect the deficiency rates, while the use of different cut-offs influences results and heterogeneity for vitamin E, but not A. CONCLUSIONS: Fat-soluble vitamins deficiency is frequent in CP patients, with considerable heterogeneity. There is, however, no apparent increased risk of vitamin D deficiency in CP compared to controls. Larger, high-quality studies are necessary to better estimate the prevalence of fat-soluble vitamins deficiency, including vitamin K.

Pancreatitis aguda secundaria a malformación arteriovenosa / Acute pancreatitis due to venous artery malformation

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