Predicting liver-related events in NAFLD: A predictive model.

BACKGROUND AND AIMS: Management of NAFLD involves noninvasive prediction of fibrosis, which is a surrogate for patient outcomes. We aimed to develop and validate a model predictive of liver-related events (LREs) of decompensation and/or HCC and compare its accuracy with fibrosis models. APPROACH AND RESULTS: Patients with NAFLD from Australia and Spain who were followed for up to 28 years formed derivation (n = 584) and validation (n = 477) cohorts. Competing risk regression and information criteria were used for model development. Accuracy was compared with fibrosis models using time-dependent AUC analysis. During follow-up, LREs occurred in 52 (9%) and 11 (2.3%) patients in derivation and validation cohorts, respectively. Age, type 2 diabetes, albumin, bilirubin, platelet count, and international normalized ratio were independent predictors of LRE and were combined into a model [NAFLD outcomes score (NOS)]. The NOS model calibrated well [calibration slope, 0.99 (derivation), 0.98 (validation)] with excellent overall performance [integrated Brier score, 0.07 (derivation) and 0.01 (validation)]. A cutoff ≥1.3 identified subjects at a higher risk of LRE, (sub-HR 24.6, p < 0.001, 5-year cumulative incidence 38% vs 1.0%, respectively). The predictive accuracy at 5 and 10 years was excellent in both derivation (time-dependent AUC,0.92 and 0.90, respectively) and validation cohorts (time-dependent AUC,0.80 and 0.82, respectively). The NOS was more accurate than the fibrosis-4 or NAFLD fibrosis score for predicting LREs at 5 and 10 years ( p < 0.001). CONCLUSIONS: The NOS model consists of readily available measures and has greater accuracy in predicting outcomes in patients with NAFLD than existing fibrosis models.

ABIDE: An Accurate Predictive Model of Liver Decompensation in Patients With Nonalcoholic Fatty Liver-Related Cirrhosis.

BACKGROUND AND AIMS: Nonalcoholic fatty liver disease (NAFLD) is an increasingly important cause of liver cirrhosis and subsequent complications. We retrospectively developed and validated a model to predict hepatic decompensation in patients with NAFLD and cirrhosis and compared this with currently available models. APPROACH AND RESULTS: Baseline variables from an international cohort of 299 patients with biopsy-proven NAFLD with compensated cirrhosis were examined to construct a model using competing risk multivariate regression and Akaike/Bayesian information criteria. Validation was performed in 244 patients with biopsy-proven NAFLD cirrhosis from the United States. Prognostic accuracy was compared with the NAFLD fibrosis score (NFS), fibrosis-4 (FIB-4), Model for End-Stage Liver Disease (MELD), Child-Turcotte-Pugh (CTP), and albumin-bilirubin (ALBI)-FIB-4 score using time-dependent area under the curve (tAUC) analysis. During a median follow-up of 5.6 years (range 2.4-14.1) and 5.4 years (range 1.5-13.8), hepatic decompensation occurred in 81 and 132 patients in the derivation and validation cohorts, respectively. In the derivation cohort, independent predictors of hepatic decompensation (Aspartate aminotransferase/alanine aminotransferase ratio, Bilirubin, International normalized ratio, type 2 Diabetes, and Esophageal varices) were combined into the ABIDE model. Patients with a score ≥4.1 compared with those with a score <4.1 had a higher risk of decompensation (subhazard ratio, 6.7; 95% confidence interval [CI], 4.0-11.2; P < 0.001), a greater 5-year cumulative incidence (37% vs. 6%, P < 0.001), and shorter mean duration to decompensation (3.8 vs 6.7 years, P < 0.001). The accuracy of the ABIDE model at 5 years was good in the derivation (tAUC, 0.80; 95% CI, 0.73-0.84) and validation cohorts (0.78; 95% CI, 0.74-0.81) and was significantly more accurate than the NFS (0.72), FIB-4 (0.74), MELD (0.69), CTP (0.72), and ALBI-FIB-4 (0.73) (all P < 0.001). CONCLUSIONS: In patients with NAFLD and compensated cirrhosis, ABIDE, a predictive model of routine clinical measures, predicts future hepatic decompensation.

Type 2 Diabetes and Metformin Use Associate With Outcomes of Patients With Nonalcoholic Steatohepatitis-Related, Child-Pugh A Cirrhosis.

BACKGROUND & AIMS: Factors that affect outcomes of patients with nonalcoholic steatohepatitis (NASH)-related cirrhosis are unclear. We studied associations of type 2 diabetes, levels of hemoglobin A1c (HbA1c), and use of antidiabetic medications with survival and liver-related events in patients with NASH and compensated cirrhosis. METHODS: We collected data from 299 patients with biopsy-proven NASH with Child-Pugh A cirrhosis from tertiary hospitals in Spain, Australia, Hong Kong, and Cuba, from April 1995 through December 2016. We obtained information on the presence of type 2 diabetes, level of HbA1c, and use of antidiabetic medications. Cox proportional and competing risk models were used to estimate and compare rates of transplant-free survival, hepatic decompensation, and hepatocellular carcinoma (HCC). RESULTS: A total of 212 patients had type 2 diabetes at baseline and 8 of 87 patients developed diabetes during a median follow-up time of 5.1 years (range, 0.5-10.0 y). A lower proportion of patients with diabetes survived the entire follow-up period (38%) than of patients with no diabetes (81%) (adjusted hazard ratio [aHR], 4.23; 95% CI, 1.93-9.29). Higher proportions of patients with diabetes also had hepatic decompensation (51% vs 26% of patients with no diabetes; aHR, 2.03; 95% CI, 1.005-4.11) and HCC (25% vs 7% of patients with no diabetes; aHR, 5.42; 95% CI, 1.74-16.80). Averaged annual HbA1c levels over time were not associated with outcomes. Metformin use over time was associated with a significant reduction in risk of death or liver transplantation (aHR, 0.41; 95% CI, 0.26-0.45), hepatic decompensation (aHR, 0.80; 95% CI, 0.74-0.97), and HCC (aHR, 0.78; 95% CI, 0.69-0.96). Metformin significantly reduced the risk of hepatic decompensation and HCC only in subjects with HbA1c levels greater than 7.0% (aHR, 0.97; 95% CI, 0.95-0.99 and aHR, 0.67; 95% CI, 0.43-0.94, respectively). CONCLUSIONS: In an international cohort of patients with biopsy-proven NASH and Child-Pugh A cirrhosis, type 2 diabetes increased the risk of death and liver-related outcomes, including HCC. Patients who took metformin had higher rates of survival and lower rates of decompensation and HCC.

Fibrosis Severity as a Determinant of Cause-Specific Mortality in Patients With Advanced Nonalcoholic Fatty Liver Disease: A Multi-National Cohort Study.

BACKGROUND & AIMS: Little is known about the natural course of nonalcoholic fatty liver disease (NAFLD) with advanced fibrosis. We describe long-term outcomes and evaluate the effects of clinical and histologic parameters on disease progression in patients with advanced NAFLD. METHODS: We conducted a multi-national study of 458 patients with biopsy-confirmed NAFLD with bridging fibrosis (F3, n = 159) or compensated cirrhosis (222 patients with Child-Turcotte-Pugh scores of A5 and 77 patients with scores of A6), evaluated from April 1995 through November 2013 and followed until December 2016, death, or liver transplantation at hepatology centers in Spain, Australia, Hong Kong, and Cuba. Biopsies were re-evaluated and scored; demographic, clinical, laboratory, and pathology data for each patient were collected from the time of liver biopsy collection. Cox proportional and competing risk models were used to estimate rates of transplantation-free survival and major clinical events and to identify factors associated with outcomes. RESULTS: During a mean follow-up time of 5.5 years (range, 2.7-8.2 years), 37 patients died, 37 received liver transplants, 88 had initial hepatic decompensation events, 41 developed hepatocellular carcinoma, 14 had vascular events, and 30 developed nonhepatic cancers. A higher proportion of patients with F3 fibrosis survived transplantation-free for 10 years (94%; 95% confidence interval [CI], 86%-99%) than of patients with cirrhosis and Child-Turcotte-Pugh A5 (74%; 95% CI, 61%-89%) or Child-Turcotte-Pugh A6 (17%; 95% CI, 6%-29%). Patients with cirrhosis were more likely than patients with F3 fibrosis to have hepatic decompensation (44%; 95% CI, 32%-60% vs 6%, 95% CI, 2%-13%) or hepatocellular carcinoma (17%; 95% CI, 8%-31% vs 2.3%, 95% CI, 1%-12%). The cumulative incidence of vascular events was higher in patients with F3 fibrosis (7%; 95% CI, 3%-18%) than cirrhosis (2%; 95% CI, 0%-6%). The cumulative incidence of nonhepatic malignancies was higher in patients with F3 fibrosis (14%; 95% CI, 7%-23%) than cirrhosis (6%; 95% CI, 2%-15%). Death or transplantation, decompensation, and hepatocellular carcinoma were independently associated with baseline cirrhosis and mild (<33%) steatosis, whereas moderate alcohol consumption was associated with these outcomes only in patients with cirrhosis. CONCLUSIONS: Patients with NAFLD cirrhosis have predominantly liver-related events, whereas those with bridging fibrosis have predominantly nonhepatic cancers and vascular events.

Increasing Incidence of Nonalcoholic Steatohepatitis as an Indication for Liver Transplantation in Australia and New Zealand.

The worldwide increase in obesity and diabetes has led to predictions that nonalcoholic steatohepatitis (NASH) will become the leading indication for orthotopic liver transplantation (OLT). Data supporting this prediction from outside the United States are limited. Thus, we aimed to determine trends in the frequency of NASH among adults listed and undergoing OLT in Australia and New Zealand (ANZ) from 1994 to 2017. Data from the ANZ Liver Transplant Registry were analyzed with patients listed for fulminant liver failure, retransplantation, or multivisceral transplants excluded. Nonparametric trend, Spearman rank correlation, and regression analysis were used to assess trends in etiologies of liver disease over time. Of 5016 patient wait-list registrants, a total of 3470 received an OLT. The percentage of patients with NASH activated for OLT increased significantly from 2.0% in 2003 to 10.9% in 2017 (trend analyses; P < 0.001). In 2017, NASH was the third leading cause of chronic liver disease (CLD) among wait-list registrants behind chronic hepatitis C virus (HCV; 29.5%) and alcohol (16.1%). Similarly, significant increases over time in the percentage of patients undergoing OLT were observed for HCV and NASH (all trend analyses; P < 0.001) but with significant reductions in primary sclerosing cholangitis and cryptogenic cirrhosis (both P < 0.05). By 2017, NASH was the third leading cause of liver disease among patients undergoing OLT (12.4%) and behind chronic HCV (30.2%) and alcohol (18.2%). NASH also became the third most frequent etiology of CLD in patients transplanted (13.8%) with concomitant hepatocellular carcinoma by 2017. In conclusion, NASH is increasing as a primary etiology of liver disease requiring listing and liver transplantation in ANZ.

Development and validation of a noninvasive prediction model for nonalcoholic steatohepatitis resolution after lifestyle intervention.

UNLABELLED: Liver biopsy is the gold standard method to assess nonalcoholic steatohepatitis (NASH) resolution after therapeutic interventions. We developed and validated a simple and noninvasive scoring system to predict NASH resolution without fibrosis worsening after 1 year of lifestyle intervention. This was a prospective cohort study conducted in 261 patients with histologically proven NASH who were treated with lifestyle changes for 52 weeks and underwent a second liver biopsy to confirm NASH resolution. We divided the data into development (140 subjects) and validation (121 individuals) sets. NASH resolution occurred in 28% (derivation group) and 27% (validation group). At the multivariable analysis, weight loss (odds ratio [OR] = 2.75, 95% confidence interval [CI] 1.65-4.58; P < 0.01), type 2 diabetes (OR = 0.04, 95% CI 0.005-0.49; P = 0.01), normal levels of alanine aminotransferase at the end of intervention (OR = 9.84, 95% CI 2.21-44.1; P < 0.01), age (OR = 0.89, 95% CI 0.83-0.97; P = 0.01), and a nonalcoholic fatty liver activity score ≥5 (OR = 0.08, 95% CI 0.01-0.43; P < 0.01) were independent predictors of NASH resolution. The area under the receiver operating characteristic curve of the selected model was 0.956 and 0.945 in the derivation and validation cohorts, respectively. Using a score threshold of ≤46.15, negative predictive values were 92% in the derivation and validation groups, respectively. By applying a cutoff ≥69.72, positive predictive values were 92% and 89% in the derivation and validation groups, respectively. Using both cutoffs, a liver biopsy would have been avoided in 229 (88%) of 261 patients, with a correct prediction in 209 (91%) CONCLUSIONS: A noninvasive prediction model including weight loss, type 2 diabetes, alanine aminotransferase normalization, age, and a nonalcoholic fatty liver activity score ≥5 may be useful to identify NASH resolution in patients under lifestyle intervention. (Hepatology 2016;63:1875-1887).

Serum biomarkers can predict a change in liver fibrosis 1 year after lifestyle intervention for biopsy-proven NASH.

BACKGROUND & AIMS: The dynamic response of serum fibrosis biomarkers to histological changes within the liver following lifestyle intervention (LI) is unknown. We explored relationships between changes in serum biomarkers and liver fibrosis in NASH patients undergoing LI. METHODS: Paired liver biopsies were performed in 261 NASH patients to assess fibrosis change after 1 year of LI. We explored the utility of serum fibrosis markers to predict changes in hepatic fibrosis and developed and internally validated a model for predicting fibrosis improvement in patients with baseline fibrosis. RESULTS: Regression, stabilization and worsening of fibrosis occurred in 51 (20%), 165 (63%) and 45 (17%) patients respectively. By multivariable analysis, change in HbA1c (OR, 0.39, P<.01), platelets (OR, 1.22, P<.01) and NFS (OR, 0.27, P<.01), as well as ALT normalization (OR, 9.7, P<.01) were independently associated with fibrosis improvement, whereas change in platelets (OR, 0.96, P<.01), and NFS (OR, 1.8, P<.01) as well as ALT normalization (OR, 0.21, P<.01) were linked to fibrosis progression. A model, including change in HbA1c, platelet and ALT normalization, was significantly more accurate (AUC of 0.96, 95% CI, l0.94-0.99) than NFS, FIB-4 and APRI for predicting fibrosis improvement. Using a threshold of ≥0.497, positive and negative predictive values were 94% (95% CI, 84-98) and 91% (95% CI, 81-96) respectively. CONCLUSIONS: Change in NFS, platelets and ALT normalization are associated with change in liver fibrosis after 1 year of LI. A model including change in HbA1c, platelet and ALT normalization discriminated patients with fibrosis improvement significantly better than other biomarkers.

Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis.

BACKGROUND & AIMS: It is not clear how weight loss affects histologic features of liver in patients with nonalcoholic steatohepatitis (NASH). We examined the association between the magnitude of weight loss through lifestyle modifications and changes in histologic features of NASH. METHODS: We conducted a prospective study of 293 patients with histologically proven NASH who were encouraged to adopt recommended lifestyle changes to reduce their weight over 52 weeks, from June 2009 through May 2013, at a tertiary medical center in Havana, Cuba. Liver biopsies were collected when the study began and at week 52 of the diet and were analyzed histologically. RESULTS: Paired liver biopsies were available from 261 patients. Among 293 patients who underwent lifestyle changes for 52 weeks, 72 (25%) achieved resolution of steatohepatitis, 138 (47%) had reductions in nonalcoholic fatty liver disease activity score (NAS), and 56 (19%) had regression of fibrosis. At week fifty-two, 88 subjects (30%) had lost ≥5% of their weight. Degree of weight loss was independently associated with improvements in all NASH-related histologic parameters (odds ratios = 1.1-2.0; P < .01). A higher proportion of subjects with ≥5% weight loss had NASH resolution (51 of 88 [58%]) and a 2-point reduction in NAS (72 of 88 [82%]) than subjects who lost <5% of their weight (P < .001). All patients who lost ≥10% of their weight had reductions NAS, 90% had resolution of NASH, and 45% had regression of fibrosis. All patients who lost 7%-10% of their weight and had few risk factors also had reduced NAS. In patients with baseline characteristics that included female sex, body mass index ≥35, fasting glucose >5.5 mmol/L, and many ballooned cells, NAS scores decreased significantly with weight reductions ≥10%. CONCLUSIONS: A greater extent of weight loss, induced by lifestyle changes, is associated with the level of improvement in histologic features of NASH. The highest rates of NAS reduction, NASH resolution, and fibrosis regression occurred in patients with weight losses ≥10%.

The Natural Course of Non-Alcoholic Fatty Liver Disease.

Non-alcoholic fatty liver disease (NAFLD) is the most prevalent form of chronic liver disease in the world, paralleling the epidemic of obesity and Type 2 diabetes mellitus (T2DM). NAFLD exhibits a histological spectrum, ranging from "bland steatosis" to the more aggressive necro-inflammatory form, non-alcoholic steatohepatitis (NASH) which may accumulate fibrosis to result in cirrhosis. Emerging data suggests fibrosis, rather than NASH per se, to be the most important histological predictor of liver and non-liver related death. Nevertheless, only a small proportion of individuals develop cirrhosis, however the large proportion of the population affected by NAFLD has led to predictions that NAFLD will become a leading cause of end stage liver disease, hepatocellular carcinoma (HCC), and indication for liver transplantation. HCC may arise in non-cirrhotic liver in the setting of NAFLD and is associated with the presence of the metabolic syndrome (MetS) and male gender. The MetS and its components also play a key role in the histological progression of NAFLD, however other genetic and environmental factors may also influence the natural history. The importance of NAFLD in terms of overall survival extends beyond the liver where cardiovascular disease and malignancy represents additional important causes of death.

Risk factors associated with the development of hyperamylasemia and post-ERCP pancreatitis in the Cuban National Institute.

CONTEXT: Acute pancreatitis is the most common complication in ERCP, and some risk factors were associated with the development of hyperamylasemia and post-ERCP pancreatitis. OBJECTIVES: identifying new factors associated with the development of hyperamylasemia or post-ERCP pancreatitis in patients attended at our center. MATERIAL AND METHODS: A (retrospective) cohort study was carried out in 170 patients on which a diagnostic-therapeutic ERCP was done due to biliopancreatic disease. 67 patients developed hyperamylasemia (39.4%) and 6 post-ERCP pancreatitis (3.5%). The following diagnostic criteria were applied: Hyperamylasemia: increase in the serum amylase level above the normal value (90 I/U). Acute post-ERCP pancreatitis: clinical: continuous abdominal pain for over 24 hours and biochemical: elevation of amylase3 times above normal value (90 U/I). RESULTS: The number of cannulations more than 4 (19 patients), (p=0.006; RR= 3.00) was associated significantly with the development of hyperamylasemia and the placing of biliary stent (14 patients), (p=0.00; RR= 0.39) was a protective factor. The factors associated with the development of post-ERCP pancreatitis were related with the patient (peridiverticular location of the papilla (p=0.00; RR= 2.00) and the sphincter of Oddi dysfunction (p=0.000; RR=1.20). CONCLUSION: Technical factors were associated with the development of hyperamylasemia, however, the factors associated with the development of post-ERCP pancreatitis in our universe of study were related mainly with the patient.

[Nonalcoholic fatty liver disease. A current perspective]. / Enfermedad hepática por depósitos grasos. Una perspectiva actual.

A review about nonalcoholic fatty liver disease is presented, considering the updated aspects related to pathophysiology, diagnosis and management of this medical condition.

Impaired glucose metabolism increases risk of hepatic decompensation and death in patients with compensated hepatitis C virus-related cirrhosis.

BACKGROUND: Glucose metabolism abnormalities frequently coexist with liver cirrhosis; however, the impact of these on liver-related outcomes has not been fully investigated. AIMS: We examined the influence of glucose abnormalities on overall mortality and liver-related complications in cirrhotic patients. METHODS: A prospective cohort of 250 subjects with compensated hepatitis C virus-related cirrhosis and without known diabetes underwent an oral glucose tolerance test and were subsequently followed for a median 201 weeks. RESULTS: At baseline, 67 (27%) had type 2 diabetes. During follow-up, 28 deaths and 55 first events of decompensation occurred. After adjustment for potential confounding covariates, overall mortality/liver transplant (sHR: 2.2, 95% CI: 1.04-4.6, P=0.04) and hepatic decompensation events (sHR: 1.9, 95% CI: 1.05-3.3, P=0.03) were significantly higher in diabetic patients. Subjects with a HOMA-IR >5 showed higher rates of mortality (sHR: 2.2, 95% CI: 1.03-4.8, P=0.04). The rates of hepatic decompensation were higher in patients with HOMA-IR >3 (sHR: 1.7, 95% CI: 1.04-2.9, P=0.03). Overall, 2h-plasma glucose was the most robust predictor of overall mortality (sHR: 2.5, 95% CI: 1.03-6, P=0.04) and decompensation (sHR: 2.7, 95% CI: 1.4-5.5, P<0.01). CONCLUSIONS: In compensated HCV-related cirrhotic patients, diabetes and marked insulin resistance are independently associated with poorer overall survival and increased risk of hepatic decompensation.

Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial.

OBJECTIVES: Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis. DESIGN: A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child-Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks. RESULTS: Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child-Pugh classes B or C, but not among patients with Child-Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated. CONCLUSIONS: The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV-related decompensated cirrhosis. Trial registration number http://ClinicalTrials.gov (NCT00502086).

Validación de técnica inmunoquímica para detección de sangre oculta en heces / Validation of an immunochemical technique for the detection of fecal occult blood

ANTECEDENTES: el cáncer colorrectal es prevenible y responde de manera efectiva al tratamiento cuando se diagnostica en etapas tempranas. La determinación de sangre oculta en heces es un método usado para el cribado de este en etapas precoces y de su lesión precursora, el adenoma. ,OBJETIVOS: 1) determinar la validez y reproducibilidad del test inmunoquímico RapiLat-Hemo en el diagnóstico de cáncer colorrectal y adenomas y comparar con el reactivo de referencia (SPIN-FOB). 2) describir los hallazgos endoscópicos más frecuentes en pacientes con sangre oculta en heces positiva, 3) describir la localización del cáncer colorrectal en los pacientes con test inmunoquímico RapiLat-Hemo positivo. MÉTODOS: se realizó un estudio de validación de un nuevo test inmunoquímico cubano (RapiLat-Hemo), para detectar SOH, incluyendo a 161 pacientes atendidos en consulta de colon, del Instituto de Gastroenterología de la Habana, en el período 2008-2010, con indicación de colonoscopia, quienes reunieron los criterios de inclusión. A todos los pacientes se les realizó determinación de SOH (RapiLat-Hemo), y se correlacionaron estos resultados con los del reactivo de referencia y la colonoscopia. RESULTADOS: predominó sexo femenino y ≤ 60 años de edad. Se obtuvo una sensibilidad de la prueba para identificar a pacientes con CCR de 88,2% y una especificidad de 92,4 %; una sensibilidad de 60,0 % para pacientes con adenomas ≥10 mm y una especificidad de 85,3 %. CONCLUSIONES: el test demostró validez y reproducibilidad adecuadas en el diagnóstico de cáncer colorrectal y adenomas ≥ 10 mm. Hubo concordancia con el reactivo de referencia (SPIN-FOB). Los hallazgos endoscópicos más frecuentes fueron: pólipos, cáncer colorrectal, y divertículos. La localización más frecuente del cáncer colorrectal en pacientes con sangre oculta en heces positiva fue hacia segmentos más distales del colon.

BACKGROUND: colorectal cancer is preventable and responds effectively to treatment when diagnosed at an early stage. Determination of fecal occult blood is a method used to screen for early colorectal cancer and its precursor lesion, the adenoma. OBJECTIVES: 1) determine the validity and reproducibility of the RapiLat-Hemo immunochemical test to diagnose colorectal cancer and adenomas, and compare it with the reference reagent (SPIN-FOB), 2) describe the most frequent endoscopic findings in patients with positive fecal occult blood, 3) describe the location of colorectal cancer in patients with positive RapiLat-Hemo immunochemical tests. METHODS: A validation study was conducted of a new Cuban immunochemical test (RapiLat-Hemo) to detect FOB. The study sample was composed of 161 patients attending colon consultation at the Institute of Gastroenterology of Havana in the period 2008-2010 who were undergoing colonoscopy and met the inclusion criteria. All patients underwent FOB determination (RapiLat-Hemo), and results were correlated with those of the reference reagent and colonoscopy. RESULTS: There was a predominance of the female sex and the ≤ 60 age group. The test for detection of colorectal cancer had a sensitivity of 88.2% and a specificity of 92.4%. For detection of ≥10 mm adenomas, sensitivity was 60.0% and specificity 85.3%. CONCLUSIONS: The test showed adequate validity and reproducibility for the diagnosis of colorectal cancer and ≥ 10 mm adenomas. There was concordance with the reference reagent (SPIN-FOB). The most common endoscopic findings were polyps, colorectal cancer and diverticula. The most common colorectal cancer location in patients with positive fecal occult blood was the most distal segments of the colon.

Validación de técnica inmunoquímica para detección de sangre oculta en heces / Validation of an immunochemical technique for the detection of fecal occult blood

Antecedentes: el cáncer colorrectal es prevenible y responde de manera efectiva al tratamiento cuando se diagnostica en etapas tempranas. La determinación de sangre oculta en heces es un método usado para el cribado de este en etapas precoces y de su lesión precursora, el adenoma. , Objetivos: 1) determinar la validez y reproducibilidad del test inmunoquímico RapiLat-Hemo en el diagnóstico de cáncer colorrectal y adenomas y comparar con el reactivo de referencia (SPIN-FOB). 2) describir los hallazgos endoscópicos más frecuentes en pacientes con sangre oculta en heces positiva, 3) describir la localización del cáncer colorrectal en los pacientes con test inmunoquímico RapiLat-Hemo positivo. Métodos: se realizó un estudio de validación de un nuevo test inmunoquímico cubano (RapiLat-Hemo), para detectar SOH, incluyendo a 161 pacientes atendidos en consulta de colon, del Instituto de Gastroenterología de la Habana, en el período 2008-2010, con indicación de colonoscopia, quienes reunieron los criterios de inclusión. A todos los pacientes se les realizó determinación de SOH (RapiLat-Hemo), y se correlacionaron estos resultados con los del reactivo de referencia y la colonoscopia. Resultados: predominó sexo femenino y ≤ 60 años de edad. Se obtuvo una sensibilidad de la prueba para identificar a pacientes con CCR de 88,2 por ciento y una especificidad de 92,4 por ciento; una sensibilidad de 60,0 por ciento para pacientes con adenomas ≥10 mm y una especificidad de 85,3 por ciento. Conclusiones: el test demostó validez y reproducibilidad adecuadas en el diagnóstico de cáncer colorrectal y adenomas ≥ 10 mm. Hubo concordancia con el reactivo de referencia (SPIN-FOB). Los hallazgos endoscópicos más frecuentes fueron: pólipos, cáncer colorrectal, y divertículos. La localización más frecuente del cáncer colorrectal en pacientes con sangre oculta en heces positiva fue hacia segmentos más distales del colon(AU)

Background: colorectal cancer is preventable and responds effectively to treatment when diagnosed at an early stage. Determination of fecal occult blood is a method used to screen for early colorectal cancer and its precursor lesion, the adenoma. Objectives: 1) determine the validity and reproducibility of the RapiLat-Hemo immunochemical test to diagnose colorectal cancer and adenomas, and compare it with the reference reagent (SPIN-FOB), 2) describe the most frequent endoscopic findings in patients with positive fecal occult blood, 3) describe the location of colorectal cancer in patients with positive RapiLat-Hemo immunochemical tests. Methods: A validation study was conducted of a new Cuban immunochemical test (RapiLat-Hemo) to detect FOB. The study sample was composed of 161 patients attending colon consultation at the Institute of Gastroenterology of Havana in the period 2008-2010 who were undergoing colonoscopy and met the inclusion criteria. All patients underwent FOB determination (RapiLat-Hemo), and results were correlated with those of the reference reagent and colonoscopy. Results: There was a predominance of the female sex and the ≤ 60 age group. The test for detection of colorectal cancer had a sensitivity of 88.2 percent and a specificity of 92.4 percent. For detection of ≥10 mm adenomas, sensitivity was 60.0 percent and specificity 85.3 percent. Conclusions: The test showed adequate validity and reproducibility for the diagnosis of colorectal cancer and ≥ 10 mm adenomas. There was concordance with the reference reagent (SPIN-FOB). The most common endoscopic findings were polyps, colorectal cancer and diverticula. The most common colorectal cancer location in patients with positive fecal occult blood was the most distal segments of the colon(AU)

Risk factors associated with the development of hyperamylasemia and post-ERCP pancreatitis in the Cuban National Institute / Factores de riesgo con el desarrollo de la hiperamilasemia y pancreatitis post PCRE en el Cuban National Institute

Contexto: La pancreatitis aguda es la complicación más frecuente de la PCRE y algunos factores de riesgo son asociados con el desarrollo de hiperamilasemia y pancreatitis post PCRE. Objetivos: Identificar factores nuevos asociados con hiperamilasemia y pancreatitis post PCRE en pacientes que acudieron a nuestro centro. Material y métodos: Un estudio retrospectivo de cohorte se llevó a cabo en 170 pacientes en quienes se realizó una CPRE diagnóstico-terapéutica por enfermedad biliopancreática. 67 pacientes desarrollaron hiperamilasemia (39,4%) y 6 pancreatitis post PCRE (3,5%). Se aplicaron los siguientes criterios diagnósticos: Hiperamilasemia: elevación de la amilasa sérica por encima del valor normal (90IU).Pancreatitis aguda post PCRE: dolor abdominal continuo por más de 24 horas y elevación de la amilasa tres veces por encima del valor normal. Resultados: El número de canulaciones, más de 4 (19 pacientes), (p=0,006; RR= 3,00) se asoció significativamente con el desarrollo de la hiperamilasemia y la puesta de stents biliares (14 pacientes) se asoció como un factor protector (p=0,00; RR= 0,39). Los factores asociados con el desarrollo de la pancreatitis post PCRE se relacionaron con el paciente (localización peridiverticular de la papila (p=0,00; RR= 2,00) y disfunción del Esfinter de Oddi (p=0,000; RR=1,20). Conclusiones: Factores técnicos fueron asociados con el desarrollo de la hiperamilasemia, sin embargo, los relacionados con el desarrollo de la pancreatitis post PCRE fueron mayoritariamente relacionados al paciente.

Context: Acute pancreatitis is the most common complication in ERCP, and some risk factors were associated with the development of hyperamylasemia and post-ERCP pancreatitis. Objectives: identifying new factors associated with the development of hyperamylasemia or post-ERCP pancreatitis in patients attended at our center. Material and methods: A (retrospective) cohort study was carried out in 170 patients on which a diagnostic-therapeutic ERCP was done due to biliopancreatic disease. 67 patients developed hyperamylasemia (39.4%) and 6 post-ERCP pancreatitis (3.5%). The following diagnostic criteria were applied: Hyperamylasemia: increase in the serum amylase level above the normal value (90I/U). Acute post-ERCP pancreatitis: clinical: continuous abdominal pain for over 24 hours and biochemical: elevation of amylase 3 times above normal value (90U/I). Results: The number of cannulations more than 4 (19 patients), (p=0.006; RR= 3.00) was associated significantly with the development of hyperamylasemia and the placing of biliary stent (14 patients), (p=0.00; RR= 0.39) was a protective factor. The factors associated with the development of post-ERCP pancreatitis were related with the patient (peridiverticular location of the papilla (p=0.00; RR= 2.00) and the sphincter of Oddi dysfunction (p=0.000; RR=1.20). Conclusion: Technical factors were associated with the development of hyperamylasemia, however, the factors associated with the development of post-ERCP pancreatitis in our universe of study were related mainly with the patient.