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Hepatitis C virus (HCV) one-step diagnosis improves recovery in patients with active infection. However, patients with previous anti-HCV+ may be excluded. We aimed to identify and retrieve non-referred or lost-to-follow-up HCV-infected patients. All anti-HCV+ patients seen in our hospital between 2013 and 2018 were included. In the first phase, we identified anti-HCV+ patients who were not referred to the Gastroenterology Unit (GU) or lost-to-follow-up. In the second phase, recovered patients were invited for a one-step visit for liver evaluation. A total of 1330 anti-HCV+ patients were included: 21.7% had not been referred to GU, and 23.1% were lost-to-follow-up. In the second phase, 49.6% of patients were contacted, and 92.8% attended a medical consultation: 62.7% had active infection, 92.2% were treated, and 86.5% achieved SVR (ITT). We concluded that screening microbiological data and referring unidentified patients with active HCV infection directly to specialists is an effective tool in achieving HCV microelimination.

Bacteriophage-encoded lysins are increasingly reported as alternatives to combat Acinetobacter baumannii infections, for which limited therapeutic options are available. Some lysins, such as LysMK34, have a C-terminal amphipathic helix allowing them to penetrate the otherwise-impermeable outer membrane barrier. Another approach to kill Gram-negative pathogens with lysins relies on fusion of a peptide with outer membrane- permeabilizing properties to the lysin. In this work, we aimed to leverage the intrinsic antibacterial activity of LysMK34 by fusing the peptide cecropin A to its N terminus via a linker of three Ala-Gly repeats, resulting in engineered LysMK34 (eLysMK34). The engineered lysin has an improved antibacterial activity compared to that of the parental lysin, LysMK34, in terms of MICs (0.45 to 1.2 μM), killing rate, and killing extent. eLysMK34 has a ≥2-foldincreased activity against stationary-phase cells, and the bactericidal effect becomes less dependent on the intracellular osmotic pressure. In particular, colistin-resistant strains become highly susceptible to eLysMK34, and enhanced antibacterial activity is observed in complement- deactivated human serum. These observations demonstrate that fusion of a lysin with intrinsic antibacterial activity with a selected outer membrane-permeabilizing peptide is a useful strategy to further improve the in vitro antibacterial properties of such lysins., K.A. was funded by the Missions Sector, Ministry of Higher Education, Egypt. The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication. D.G. is supported by the Research Foundation-Flanders (FWO) under grant G066919N. Y.B. is a coinventor of patents related to the Artilysin field. We thank S. Malhotra-Kumar (Laboratory of Medical Microbiology, Vaccine & Infectious Disease, University of Antwerp, Antwerp, Belgium) for providing the colistin-resistant A. baumannii strains (Greek46 and Greek47) and J. P. Pirnay (Laboratory for Molecular and Cellular Technology, Queen Astrid Hospital, Neder-over-Heembeek, Belgium) for providing A. baumannii RUH134 and P. aeruginosa PA14 and Br667.

A new subcutaneous formulation of the infliximab biosimilar CT-P13 has recently been developed for the treatment of inflammatory bowel disease (IBD), providing response rates similar to intravenous treatment. The use of this new formulation was requested, in an effort to limit patient attendance at intravenous infusion centers and to maintain biological treatment during the COVID-19 pandemic. The objective of this observational, retrospective and descriptive study was to assess CT-P13 efficacy and safety after switching from intravenous to a subcutaneous formulation in patients with IBD receiving maintenance therapy. This article shows preliminary results after six months of follow-up.

Background Neonatal sepsis is a condition with high mortality and morbidity that contributes to high rates of antibiotic therapy at birth. In addition, very low birth weight newborns (VLBWN) are particularly vulnerable. Interleukin 6 (IL-6) seems to be an early and effective marker that could help a better selection of patients to be treated. This study aimed to evaluate the use of antibiotics in the first 72 hours of life in VLBW infants before and after using IL-6 as an infection marker. Also, we wanted to analyze the differences in morbidity and mortality during admission and other factors associated with the decision to start antibiotic treatment. Methods We conducted a cohort retrospective study. We included VLBWN born in our hospital or admitted before 72 hours of life in two two-year periods (2007-2008 and 2011-2012). Results Antibiotics use during the first 72 hours of life was analyzed as the primary variable, which was reduced by 20% on the second period (p = 0.002). Regarding the analysis of secondary variables, we found no significant differences in mortality during hospital admission and the incidence of nosocomial sepsis, enterocolitis, or invasive fungal infection. The multivariate analysis indicated extreme prematurity and the study group as the most strongly related factors to the start of antibiotic therapy. Conclusions IL-6 was a useful marker of infection to reduce the use of antibiotic therapy in VLBW infants without increasing mortality.

A new subcutaneous formulation of the infliximab biosimilar CT-P13 has recently been developed for the treatment of inflammatory bowel disease (IBD), providing response rates similar to intravenous treatment. The use of this new formulation was requested, in an effort to limit patient attendance at intravenous infusion centers and to maintain biological treatment during the COVID-19 pandemic. The objective of this observational, retrospective and descriptive study was to assess CT-P13 efficacy and safety after switching from intravenous to a subcutaneous formulation in patients with IBD receiving maintenance therapy. This article shows preliminary results after six months of follow-up.

[Purpose] Stenting as a bridge to surgery (SBTS) can transform an emergency surgery (ES) into an elective surgery in patients with symptomatic left-sided malignant colonic obstruction. Concerns have been raised regarding short-term morbidity and long-term oncologic outcomes, with contrasting results reported in the literature. Our main aim is to evaluate not only long-term oncologic outcomes but also short-term postoperative outcomes of stented patients who underwent elective surgery compared to those who had ES., [Methods] From January 2006 to May 2012, we retrospectively identified patients with confirmed left-sided colorectal cancer obstruction. This was done in two centers of reference of colorectal diseases in southern Spain with patients who were treated with curative intent either with ES or SBTS. The short- and long-term results were compared between both groups., [Results] There were 71 patients in the stenting group and 66 in the emergency surgery group, with similar demographic data. Initial stoma creation rates were lower in the SBTS group (16.9% vs. 54.5%, p, [Conclusions] The use of SBTS reduces ostomy rates in patients with obstructive colon malignancies. Long-term survival results are similar. Patients in the SBTS group with stage III AJCC status showed a higher 5-year recurrence-free survival rate than those in the ES group.

INTRODUCTION The primary goal of this study was to compare gastrointestinal symptom reduction in patients on bismuth-containing quadruple eradication therapy supplemented with Lactobacillus reuteri strains (DSM 17938 and ATCC PTA 6475) or placebo. MATERIALS AND METHODS This was randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Patients received first-line an eradication regimen based on bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (three-in-one capsules), and omeprazole 40 mg twice a day for ten days, plus a probiotic or placebo tablet for 30 days. During follow-up gastrointestinal symptoms were assessed using an evaluation scale (GSRS), and adverse events were collected at 0, 14, 28, and 56 days. RESULTS A total of 80 patients were included from February 2018 to May 2019 at a single site. Eradication therapy was effective for 85% of patients, with no differences between treatment arms. In the group receiving the probiotic, abdominal pain decreased in 42% of patients, compared with 19% in the control group (OR: 0.27; CI, 0.13-0.58; p < 0.001), and abdominal distension decreased in 25% versus 17% in the control group (OR: 0.24; IC, 0.19-0.84; p < 0.001); Conclusions: Treatment with L. reuteri only reduced abdominal pain and distension. Further studies are needed to establish the role of probiotics as adjuvant therapy in H. pylori eradication.

[Introduction] patients with advanced chronic liver disease (CLD) may be at an increased risk of a severe course due to cirrhosis-associated immune dysfunction. The aim of this study was to determine the prevalence of CLD in COVID-19 patients and to analyze the course of the infection, compared with patients with non-liver disease., [Materials and methods] this was a retrospective single center study of all patients with a positive SARS-CoV-2 polymerase chain reaction (PCR) test from March 23rd to April 30th, 2020. Clinical and biochemical data of patients with and without CLD and COVID-19 were collected from the medical records., [Result] four hundred and forty-seven patients with a SARS-CoV-2 positive PCR were included, 6.3 % had CLD; 69.7 % of patients with CLD were male, with a median age of 65.5 years and active alcohol consumption and smoking; 75 % had non-advanced liver fibrosis and most had non-alcoholic fatty liver disease (NAFLD). The hospital admission rate (92.9 % vs 47.7 %, p < 0.001), concomitant comorbidities (diabetes 38.5 vs 16.5 %, p = 0.011; obesity 30.8 vs 8.5 %, p = 0.033; cancer 23.1 vs 5 %, p = 0.027; and chronic obstructive pulmonary disease (COPD) 19.2 vs 9 %, p = 0.009) and concomitant antibiotics treatment (19.3 vs 5 %, p = 0.018) were higher in patients with CLD than in those without CLD. In-patient hospital mortality rates were similar in both groups (30.8 vs 19.6 %, p = 0.289). The presence of CLD was not associated with mortality (OR = 1.06; 95 % CI = 0.35-3.18; p = 0.924). However, patients with CLD and COVID-19 who were male, obese or under concomitant antibiotic treatment had the highest risk of mortality according to the univariate analysis., [Conclusion] patients with CLD had a higher risk of hospital admission, with worse outcomes during the COVID-19 infection associated to other concomitant comorbidities and a suspicion of bacterial co-infection., Financial support statement: this study was partly supported by Plan Nacional de I+D+i 2013-2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Spanish Ministry of Science and Innovation, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0001), co-financed by the European Development Regional Fund “A way to achieve Europe”, Operative Program Intelligence Growth 2014-2020.

Immunosuppressed patients are susceptible to infections by opportunistic agents such as Leishmania that could cause visceral leishmaniasis with gastrointestinal involvement in up to 10 % of cases. We report a 41-year-old man with human immunodeficiency virus (HIV) infection stage C3 with CD4 lymphocytes 81/mm3, 4,070 leukocytes (47.2 % lymphocytes, 0.0 % eosinophils, rest of differential normal) treated with antiretroviral therapy (dolutegravir/abacavir/lamivudine) with good adherence. He also reported mesangiocapillary glomerulonephritis type-1, hepatocutaneous porphyria, and a 7-year history of recurrent visceral leishmaniasis treated with liposomal amphotericin B as secondary prophylaxis. Esophagogastroduodenoscopy and colonoscopy indicated for chronic diarrhea and anemia performed 5 years ago displayed antral erythema, mild nodular appearance in the duodenal mucosa, and normal colonic mucosa. Gastric, duodenal, and colonic biopsies revealed Leishmania spp despite treatment with liposomal amphotericin B. A video capsule endoscopy (VCE) was now indicated for persistent diarrhea. Enteropathy with atrophic and patchy, marked edema of the villus, and whitish nodularity with a “river bedrock” appearance ([Fig. 1 – 3]) in the duodenum and jejunum were identified ([Video 1]). Further gastric and duodenal biopsies showed an accumulation of macrophages in the lamina propria of the mucosa with intracytoplasmatic Leishmania spp ([Fig. 4]). Treatment with meglumine antimoniate was initiated owing to previous failure with liposomal amphotericin B, without response.

Primary follicular lymphomas (FL) of the gastrointestinal (GI) tract are very rare and constitute < 4 % of all non-Hodgkin's lymphomas at this location. We report our experience with primary FL of the GI tract.

The incidence of biliary stent migration is low, and most cases are asymptomatic, with elimination of the piece by the feces. We report the case of a patient with an ileal perforation secondary to a plastic biliary stent migration. Intestinal perforation due to stent migration is an extremely rare complication, being mostly located at duodenum. Patients with previous surgeries, diverticulosis or abdominal wall hernias have a higher risk of complications in case of prosthetic migration, that is the reason why they require special attention and follow-up.

We report the case of a 67-year-old male who was referred to our hospital due to severe abdominal pain and fever. His past medical history included a total gastrectomy surgery for stomach cancer. Abdominal examination showed intense pain on deep palpation in the epigastric region. Laboratory test revealed elevated C-reactive protein (235 mg/l) and amylase (1,789 U/l). Computerized tomography reported a pancreatic collection with the presence of air bubbles inside and areas of necrotic pancreatic parenchyma.

Preterm infants have a higher risk of showing visuospatial memory impairment, the function that allows to encode and remember visual and spatial information. It has been studied in late childhood in preterm children. Studies on visuospatial memory throughout the first 2 years of life are still scarce. Behavior, temperament, and overall cognition could be altered in preterm children affecting memory performance. Therefore, the main aim of this study was to evaluate short-term and visuospatial working memory performance in a preterm sample followed longitudinally at 12, 15, 18, and 22 months (N = 15), and compare their performance with that of full-term children (N = 65). The secondary aim was to analyze the course of mnesic development in preterm infants and relate their memory performance to other cognitive abilities and behavioral tendencies. Assessment included previously published tasks and an experimental paradigm. Results showed that preterm children scored lower than full-term children on visuospatial short-term and working memory at 12 and 22 months of age, although these results varied depending on the memory test used. Preterm children's memory results showed that these skills improve in this population between the first and second year of life. Finally, memory performance was directly associated with the level of cognitive development and the presence of proactive behaviors, while being inversely correlated with the presence of disruptive behaviors and a difficult temperamental style. These preliminary findings suggest that it is possible to detect visuospatial memory difficulties in the preterm population before the age of two.

espanolIntroduccion: cuando no se dispone de leche materna propia, la leche materna donada es la mejor alternativa para asegurar los requerimientos nutricionales de los recien nacidos prematuros o enfermos. Objetivos: conocer el contenido de macronutrientes de la leche materna donada y como varian estos en los distintos periodos de la lactancia. Material y metodos: se analizo de forma retrospectiva la composicion nutricional de 822,423 litros de leche materna donada, procedentes de 160 donantes del banco de leche materna de un hospital de tercer nivel entre el 1 de febrero de 2017 y el 31 de diciembre de 2019. Resultados: el contenido en lipidos y carbohidratos se mantiene constante a lo largo de la lactancia; sin embargo, el contenido proteico disminuye inicialmente para luego volver a aumentar a partir del segundo ano de lactancia. Conclusiones: los bancos de leche materna deben conocer las variaciones del contenido en macronutrientes de la leche donada para optimizar la nutricion del recien nacido prematuro. EnglishIntroduction: when own mother´s breast milk is unavailable, donor human milk is the best option to guarantee the nutritional requirements of preterm or ill newborns. Objectives: to analyze the macronutrient composition of donor breast milk and its evolution over lactation periods. Material and methods: we retrospectively analyzed the nutritional composition of 822.423 L of donor breast milk from 160 donors at the human milk bank of a third-level hospital between February 1, 2017 and December 31, 2019. Results: lipid and carbohydrate composition remains constant throughout lactation. However, protein content decreases initially to increase again starting in the second year of lactation. Conclusions: donor human milk banks should be aware of the variations in macronutrient composition donor human milk shows in order to optimize nutrition for preterm newborns.

Around 27,000 people were killed in the province of Asturias during the Spanish Civil War, with several thousands killed after the war ended. There are currently over 2,000 known mass burial locations throughout Spain, but many more are unknown. Geophysics is a useful tool employed to help in the active attempts to document and improve knowledge about victims from this conflict. This paper details a non-invasive study of the Cementerio de El Salvador, in the city of Oviedo, Northern Spain. Part of the cemetery contains a known mass burial with approximately 1,300 individuals from the Spanish Civil War and post-war repression eras. Multi-frequency near-surface geophysical techniques were undertaken, after permission, to enhance knowledge about which, if any, techniques should be used to detect, delineate and analyse such mass graves. Multi-frequency (250 MHz and 500 MHz) ground-penetrating radar surveys were acquired together with 2D and 3D Electrical Resistivity Tomography datasets. The results have established the limits of the mass grave and improve the knowledge of the internal mass grave structure. The paper also shows the importance of considering the climatic conditions during data acquisition. This has important implications for the successful detection of recent historical mass burials using near-surface geophysics.

Background Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. Materials and methods This was a prospective single-center observational study in patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). All patients were switched from infliximab RP (Remicade) to CT-P13 treatment and followed up for up to 12 months. The efficacy endpoint was the change in clinical response assessed at 3-monthly intervals, according to the Harvey–Bradshaw score and partial Mayo score for patients with CD and UC, respectively. C-reactive protein (CRP) was also measured. Adverse events were monitored and recorded throughout the study. Results A total of 98 patients with inflammatory bowel disease (67 CD/31 UC) were included. A total of 83.6% (56/67) of patients with CD were in remission at the time of the switch and 62.7% were in remission at 12 months. The Harvey–Bradshaw score showed a significant change at 12 months (P=0.007) but no significant change was observed in median CRP at this timepoint (P=0.364). A total of 80.6% (25/31) of patients with UC were in remission at the time of the switch and 65.3% (18/28) were in remission at 12 months. No significant changes in the median partial Mayo score (P=0.058) or CRP (P=0.329) were observed at 12 months. Serious adverse events related to medication were reported in 11 (11.2%) patients. Conclusion Switching from infliximab RP to CT-P13 is efficacious and well tolerated in patients with CD or UC for up to 12 months.

Introduccion: la endoscopia tiene un papel fundamental en el manejo de los pacientes con colitis ulcerosa (CU), ya que permite la visualizacion y evaluacion de la gravedad de la enfermedad. No obstante, dicha evaluacion no es siempre algo objetivo, por lo que se han desarrollado diferentes escalas que pretenden homogeneizar los hallazgos. Objetico: el objetivo del estudio fue evaluar la variabilidad interobservador entre el Indice de Mayo Endoscopico (IME) y el Indice de Severidad Endoscopica de la Colitis Ulcerosa (UCEIS), al analizar la gravedad de las lesiones endoscopicas en pacientes con CU. El objetivo secundario fue analizar si la preparacion catartica afectaba al grado de concordancia entre los endoscopistas. Material y metodos: se trata de un estudio observacional comparativo de una unica cohorte a la cual se realiza una colonoscopia bajo guia de practica clinica habitual a pacientes con CU y se estadifica segun el IME y el UCEIS por tres endoscopistas expertos. Para valorar el grado de correlacion interobservador se utilizaron el indice de Kappa para el IME y el coeficiente de correlacion intraclase para el UCEIS. Se incluyeron 67 pacientes, con edad media de 51 anos (DE ± 16,7) e indice de Mayo clinico medio de 3,07 (DE ± 2,54). Resultados: el indice de Kappa ponderado entre los endoscopistas A y B para el IME fue de 0,8; entre el A y el C, de 0,52; y entre el B y el C, de 0,49. Para el UCEIS, el coeficiente de correlacion intraclase fue del 0,922 entre los tres endoscopistas (IC 95 %: 0,832-0,959). Se encontro una mejor correlacion interobservador cuando la preparacion catartica era ≥ 8 segun la escala de Boston. Conclusion: existe, por tanto, una superior correlacion entre los diferentes endoscopistas para el UCEIS que para el IME, por lo que deberia ser considerado como el mejor indice a utilizar en la practica clinica. Una buena preparacion catartica es importante para mejorar la correlacion interobservador.

Introduction between 30 % and 40 % of patients treated with infliximab lose response during maintenance. Therapeutic drug monitoring could be used to optimize management in these situations. However, infliximab serum levels are not well defined. The aim of this study was to determine the cut-off range of infliximab serum levels in Crohn's disease patients in remission in the clinical practice. Methods an observational retrospective study was performed from 2016 to 2017. Patients were included with established Crohn's disease, who had been on a maintenance dose schedule of infliximab. Infliximab levels and antibodies to infliximab were measured at least twice in all patients, after induction and after six months of treatment. Clinical remission was defined as ≤ 4 using the Harvey-Bradshaw index. Cluster analysis was used to analyze the results. Results one hundred and five Crohn's disease patients were included in the study; 57.1 % were male with a mean age of 39 years (SD ± 12.9). The median (range) time of the disease was eleven years (7-15) and the median (range) time of follow-up was 32 months (22-38). Patients who achieved remission had infliximab serum levels between 4.26-8.26 ug/ml versus 0.06-1.43 ug/ml in patients who did not achieve remission after induction. Infliximab serum levels were 2.84-7.75 ug/ml and 0.05-2.69 ug/ml in patients who achieved remission versus those who did not achieve remission after six months of treatment. Overall, 4.26-8.26 ug/ml was found to be the best cut-off range for remission. Conclusions in our clinical practice, serum levels of infliximab in Crohn's disease patients should be higher than 4 ug/ml to achieve clinical remission.

several barriers remain in the hepatitis C care cascade, which need to be removed in order to eliminate chronic hepatitis C. These barriers include deficiencies in screening and confirmatory diagnosis as well as difficulties in accessing treatment.to identify factors associated with the non-referral of patients with positive hepatitis C virus (HCV) antibodies and to identify factors associated with loss of follow-up or non-attendance of these patients to specialist consultation after referral.observational and retrospective single-center-study, including all positive HCV serology tests performed between January 2013 and May 2018, in the Virgen Macarena health area (Seville, Spain) before implementing the one-step diagnosis. Non-referred patients and patients who were lost to follow-up after being referred were identified.a total of 54 (77.4 %) patients diagnosed in Primary Care (PC) and 54 (22.2 %) from hospital specialists were not referred (p0.001). Predictors for non-referral were: stay in prison/institutionalization (p = 0.04), suffering chronic obstructive pulmonary disease (COPD) (p = 0.07), a normal AST value (p = 0.034) or test requested by Primary Care physician (PCP) (p = 0.004). Patients referred from PC were more likely to be lost to follow-up than those referred from hospital specialists (p0.001). Predictors of follow-up loss included: opioid replacement therapy (p = 0.034), absence of high blood pressure (p = 0.039) and test requested by PCP (p = 0.049).a high percentage of patients with positive HCV serology were not referred or were lost to follow-up, mainly those belonging to high risk social groups or those with associated comorbidities. Patients with average values of transaminases or those diagnosed in PC were also less frequently referred.

Introduccion y objetivos: la pandemia por el SARS-COV2 ha obligado a un cambio sustancial en la atencion a los pacientes con patologias digestivas, en especial a los pacientes con enfermedad inflamatoria intestinal (EII), por estar tratados con farmacos inmunomoduladores. En este sentido, algunas guias nacionales e internacionales han indicado las normas a tener en cuenta. No obstante, pocos trabajos han evaluado como han afrontado los pacientes esta infeccion. Por ello, hemos realizado este estudio con el objetivo de conocer como ha afectado la pandemia por SARS-COV2 a nuestros pacientes con EII. Material y metodos: se realizo una encuesta on-line entre los 295 miembros de la Asociacion de Enfermos de Crohn y Colitis Ulcerosa (ACCU) que constaba de 19 preguntas. Resultados: participaron 168 pacientes de la ACCU, de los cuales un 58 % eran mujeres, el 63,7 % tenia una EC y el 53 % recibia tratamiento biologico. Un 5 % fueron infectados por el SARS-CoV2, todos ellos varones. La principal preocupacion de los pacientes era el miedo a adquirir la infeccion (80,9 %). Mas del 90 % continuo con su tratamiento inmunosupresor y biologico. La mitad de los pacientes teletrabajaron durante el periodo de pandemia. Conclusiones: la perspectiva de los pacientes es fundamental para conseguir un adecuado manejo y evolucion de la enfermedad. Son necesarios mas trabajos que evaluen el impacto que situaciones excepcionales como la pandemia COVID-19 puede ocasionar sobre los pacientes con EII para mejorar la adherencia y el control de la enfermedad.

Splenosis is an uncommon pathology whose diagnosis requires a high index of suspicion. In most cases they are incidental findings, so their suspicion is essential to carry out a non-invasive diagnosis. We present a case of intraabadominal splenosis and perform a brief review of the literature.

Background: vedolizumab is an α4β7 integrin antagonist. The aim of this study was to evaluate the clinical response and remission rates with vedolizumab. Methods: this was a retrospective study of inflammatory bowel disease (IBD) patients who received vedolizumab between 2016 and 2019. Response and remission rates were analyzed at three, six, 12, 18 and 24 months after induction. Results: fifty-five patients were included. Clinical remission rates in CD and UC at three, six, 12, 18 and 24 months were 19.35 %, 26.67 %, 30.43 %, 30 %, 38.89 % and 29.17 %, 26.09 %, 19.05 %, 26.67 % and 20 %, respectively. Conclusions: vedolizumab is effective for induction and maintenance of clinical remission, both in Crohn’s disease and ulcerative colitis.

We present a case of arcuate ligament syndrome diagnosed in a 23-year-old patient with epigastric pain, vomiting and weight loss, using Doppler ultrasound and CT-angiography, treated by surgical resection of the ligament with complete resolution of symptoms. In addition, incidentally the patient was diagnosed with a nutcracker syndrome, without clinical repercussions.

Background/Objective: Osteoporosis and osteoporotic fracture risk are extraintestinal manifestations of the inflammatory bowel disease, whose etiopathogenic mechanisms have not been determined yet. Anti-tumor necrosis factor (TNF)-α are used in treatment of inflammatory bowel disease (IBD), but it is unknown if they play a role in osteoporotic fracture prevention. The objective of this study was to know if anti-TNF decreases fracture risk or modifies bone mineral density. To determine the possible risk factors associated with fractures, and assess the incidence of vertebral fractures in IBD patients. Methods: Longitudinal prospective cohort study (7 yr of follow-up); which included 71 IBD patients, 23 received anti-TNF-α; the remaining 48 received conventional treatment, constituted the control group. Patients participated in a questionnaire which gathered risk factors associated with the development of osteoporosis and fractures. Radiographs of the dorsolumbar-spine were performed and also a bone density measurement. Their biochemical and bone remodeling parameters were determined. Results: Although patients who did not receive anti-TNF-α, suffered more fractures but biologic therapy did not reduce the risk of new vertebral fractures. The increase of bone mass was significantly higher the group treated with anti-TNF-α. The increase in the lumbar spine was of 8% and in the femoral neck was of 6.7%. The only determinant factor for the incidence of vertebral fractures was a history of previous fractures (odds ratio of 12.8; confidence interval 95% 2.37–69.9; p = 0.003). The incidence of vertebral fractures in IBD patients was considerably high: 26.7/700 patient-yr. Conclusions: Anti-TNF-α, although increased bone mass in these patients, did not reduce the risk of new vertebral fractures. In this study, patients with IBD have a considerably high incidence of fractures. Only the existence of previous vertebral fractures was a predictive factor for consistent fractures.

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License.-- et al., [Objectives]: Treatment for celiac disease (CD) is a lifelong strict gluten-free diet (GFD). Patients should be followed-up with dietary interviews and serology as CD markers to ensure adherence to the diet. However, none of these methods offer an accurate measure of dietary compliance. Our aim was to evaluate the measurement of gluten immunogenic peptides (GIP) in stools as a marker of GFD adherence in CD patients and compare it with traditional methods of GFD monitoring. [Methods]: We performed a prospective, nonrandomized, multicenter study including 188 CD patients on GFD and 84 healthy controls. Subjects were given a dietary questionnaire and fecal GIP quantified by enzyme-linked immunosorbent assay (ELISA). Serological anti-tissue transglutaminase (anti-tTG) IgA and anti-deamidated gliadin peptide (anti-DGP) IgA antibodies were measured simultaneously. [Results]: Of the 188 celiac patients, 56 (29.8%) had detectable GIP levels in stools. There was significant association between age and GIP in stools that revealed increasing dietary transgressions with advancing age (39.2% in subjects ≥13 years old) and with gender in certain age groups (60% in men ≥13 years old). No association was found between fecal GIP and dietary questionnaire or anti-tTG antibodies. However, association was detected between GIP and anti-DGP antibodies, although 46 of the 53 GIP stool-positive patients were negative for anti-DGP. [Conclusions]: Detection of gluten peptides in stools reveals limitations of traditional methods for monitoring GFD in celiac patients. The GIP ELISA enables direct and quantitative assessment of gluten exposure early after ingestion and could aid in the diagnosis and clinical management of nonresponsive CD and refractory CD. Trial registration number NCT02711397., This work was supported by grants from Ministerio de Ciencia e Innovación and FEDER funds (DELIAC, IPT-2011-0952-900000), and Corporación Tecnológica de Andalucía (SINGLUCHECK, 1737/0118).

BACKGROUND Infliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD. METHODS An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar (CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar. RESULTS 98 patients (CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar (P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar (P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION The overall efficacy and loss of treatment response with infliximab biosimilar (CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

espanolObjetivo: evaluar la eficacia y seguridad de la terapia cuadruple con omeprazol mas “una capsula tres-en-uno” que contiene subcitrato de bismuto, metronidazol y tetraciclina (BMTO) en pacientes, naive y fracasos previos, diagnosticados de infeccion con Helicobacter pylori, en el area de Sevilla, en condiciones de practica clinica habitual. Metodos: estudio prospectivo realizado en pacientes consecutivos con infeccion confirmada por Helicobacter pylori y sintomas gastrointestinales del tracto superior. Los pacientes fueron tratados, tras firmar el consentimiento, con Pylera® (capsula tres-en-uno que contiene 140 mg de subcitrato de bismuto, 125 mg de metronidazol y 125 mg de tetraciclina) cuatro veces al dia, mas omeprazol (20 o 40 mg) dos veces al dia, durante diez dias. La erradicacion fue establecida mediante un test de urea en aliento negativo realizado, al menos, 28 dias despues de finalizar el tratamiento. Resultados: un total de 58 pacientes fueron incluidos consecutivamente, dos de ellos fueron retirados del estudio por vomitos al tercer y quinto dia, respectivamente. Diecisiete (29,3%) pacientes tenian historia previa de tratamiento de su infeccion por Helicobacter pylori. En la poblacion por intencion de tratar las tasas de erradicacion fueron del 97,6% (40/41) y del 82,4% (14/17) en los pacientes tratados con Pylera® como primera linea o como terapia de rescate, respectivamente. Veintiocho pacientes (48%) presentaron, al menos, un acontecimiento adverso, la mayoria (86%) leves. Conclusion: diez dias de tratamiento con BMTO es una estrategia eficaz y segura en pacientes con infeccion confirmada por Helicobacter pylori. EnglishObjective: To evaluate the efficacy and safety of a quadruple regimen (BMTO) of the “3-in-1 capsule” (containing bismuth subcitrate potassium, metronidazole and tetracycline) plus omeprazole in naive and previously treated patients diagnosed with Helicobacter pylori (H. pylori) infection in the clinical setting in Seville (Spain). Methods: This is a prospective study carried out on consecutive patients with a confirmed H. pylori infection and upper gastrointestinal symptoms. After providing their informed consent, the patients were treated for ten days with a 3-in-1 capsule containing bismuth subcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline (125 mg: Pylera®), three capsules four times daily, plus omeprazole (20 or 40 mg) twice daily. Eradication of infection was determined by a negative urea breath test at least 28 days after the end of treatment. Results: A total of 58 consecutive patients were enrolled into this study, two of whom withdrew early due to vomiting on days three and five, respectively. In this cohort, 17 patients (29.3%) had a prior history of medication to treat H. pylori. In the intent-to-treat population, eradication was achieved in 97.6% (40/41) and 82.4% (14/17) of cases in patients treated with BMTO as a first-line or rescue therapy, respectively. At least one adverse event was reported by 28 (48%) patients, mostly mild effects (86%). Conclusion: A ten day treatment with BMTO is an effective and safe strategy to combat confirmed H. pylori infection in patients

The slow progression of chronic hepatitis C (CHC) infection requires long observation periods to detect clinical changes. We compare the incidence of clinical events, hepatocellular carcinoma (HCC), overall mortality, liver-related mortality, and fibrosis progression between patients with a sustained virological response (SVR) and nonresponders (NR) after a 13-year follow-up period.One hundred and eighty-two CHC patients, who received interferon and ribavirin treatment between 1996 and 2000, were included. Clinical events were evaluated during follow-up. At the end of follow-up, transient elastography was used to assess fibrosis progression.Of the 182 patients, 46.7% (n=85) achieved an SVR. Twenty-seven patients developed hepatic decompensation (one SVR) and 15 developed HCC (three SVR). Twenty-nine patients died (eight SVR). Twelve of the 29 deaths were liver related (two SVR). Independent factors associated with hepatic decompensation were NR to treatment [hazard ratio (HR)=23.35; 95% confidence interval (CI): 2.90-189.25; P=0.003], advanced fibrosis at baseline (HR=9.11; 95% CI: 4.13-20.09), and treatment delay after diagnosis (HR=1.02; 95% CI: 1.00-1.03; P=0.012). Only the latter two were associated with HCC development and liver-related mortality. An assessment of liver fibrosis was performed on 125 patients (66 SVR). Fibrosis values were significantly lower in SVR patients, showing less progression to advanced stages of fibrosis [SVR: 6.6 (2.8); 95% CI: 5.8-7.3] than NR [NR: 14.0 (11.1); 95% CI: 11.1-16.9; P0.001].In patients with CHC, SVR is durable and reduces clinical events. The risk of HCC development is lower, but not eliminated. Sustained responders showed fibrosis stabilization or improved fibrosis values.

Background CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. Aims To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. Methods This is a prospective observational study in patients with moderate to severe Crohn’s disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. Results 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. Conclusions CT-P13 was efficacious and well tolerated in patients with CD or UC.

Pyoderma gangrenosum is a serious cutaneous complication seen in approximately 1 % of patients with inflammatory bowel disease (IBD). Oral corticosteroids are the mainstay treatment, although the evidence supporting their use is weak. The purpose of this study was to investigate the characteristics of pyoderma gangrenosum associated with Crohn’s disease or ulcerative colitis and which treatments are prescribed in Spanish clinical practice. In this retrospective, observational study, the medical records from all patients with IBD and a diagnosis of pyoderma gangrenosum attended by the gastroenterology departments of 12 Spanish hospitals were reviewed. Data on patient demographics and characteristics, underlying IBD and treatment, and pyoderma gangrenosum characteristics, treatment, and outcome were collected and analyzed. The data from 67 patients were analyzed (41 [61.2 %] women, 41 [61.2 %] with Crohn’s disease, 25 [37.3 %] with ulcerative colitis, and 1 [1.5 %] with indeterminate disease). The underlying disease was in remission in approximately one-third of patients at the time of presentation of pyoderma gangrenosum. Healing was achieved in all patients (in 3 without any systemic therapy). Oral corticosteroids were taken by 51 patients (76.1 %), almost always as first-line treatment, although definitive healing was attained in 19 (28.4 %). Biologic agents such as infliximab and adalimumab were taken by 31 patients (46.3 %) at some point (first-line in 6 patients [9.0 %]), with definitive healing in 29 patients (93.5 %). Oral corticosteroid therapy remains the most common treatment for pyoderma gangrenosum associated with inflammatory bowel disease. Biologic therapies such as infliximab and adalimumab should also be considered.

Background: The incidence of inflammatory bowel disease is increasing in Europe and in Spain. However, there is no recent data from Southern Spain. Objectives: To determine the evolution of the hospital incidence of inflammatory bowel disease in Southern Spain. Material and methods: A retrospective study was performed in two hospitals in Southern Spain. Data was collected from inflammatory bowel disease patients, divided into two periods (1995-2000 and 2001-2014) and compared. The reference population from both areas was 1,011,555 inhabitants. Results: A total of 430 patients were registered during the first period (1995-2000); 50% (215) had Crohn’s disease that resulted in a cumulative incidence rate of 7.08 cases/100,000 inhabitants per year. The overall inflammatory bowel disease incidence was 3.54 cases/100,000 inhabitants per year. During the second period (2001-2014), 2,089 patients were collected; 51.7% had ulcerative colitis (1,081). The rate of cumulative incidence of inflammatory bowel disease was 14.7 cases/100,000 inhabitants per year (7.6 cases of ulcerative colitis/100,000 inhabitants/year and 7.1 cases of Crohn´s disease/100,000 inhabitants/year). Conclusions: The incidence of inflammatory bowel disease in Southern Spain has doubled in the last decade and is similar to that of the rest of the country and Europe.

CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. This is a prospective observational study in patients with moderate to severe Crohn’s disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. CT-P13 was efficacious and well tolerated in patients with CD or UC.

espanolIntroduccion: el esofago de Barrett (EB) es una enfermedad adquirida definida por la presencia de metaplasia intestinal en el esofago distal. Su prevalencia se ha incrementado de forma alarmante en los ultimos anos. Objetivos: los objetivos primarios del presente trabajo fueron analizar el comportamiento del EB y del adenocarcinoma esofagico (ACE) en un area sanitaria espanola durante el seguimiento del periodo del estudio. Metodos: se analizaron caracteristicas sociodemograficas y el consumo de alcohol y tabaco. Tambien se valoro el comportamiento histologico asi como las causas de defuncion en cada uno de los grupos. Resultados: se incluyeron 430 pacientes, 338 con EB y 92 con ACE. La tasa de incidencia paso de 2,25 y 1,25 por 100.000 habitantes en 1996 a 6,5 y 4,75 en 2011, en EB y ACE, respectivamente. Hubo mas varones, mayor edad e ingesta etilica en el grupo adenocarcinoma respecto al grupo de Barrett. La supervivencia del ACE fue de 23 meses. Las principales causas de muerte en los pacientes con Barrett fueron el cancer no esofagico y la enfermedad cardiovascular. Conclusiones: existe una mayor incidencia y prevalencia tanto del EB como del ACE en los ultimos anos. Como factores de riesgo encontramos el sexo masculino, mayor edad y consumo de alcohol. El EB largo (> 3 cm) esta implicado en la progresion de la displasia. El diagnostico de ACE se hace, la mayor parte de las veces, con el debut de la enfermedad neoplasica y, en el menor de los casos, sobre un EB previo. La enfermedad cardiovascular y neoplasica no esofagica han sido las principales causas de mortalidad en los pacientes con EB. EnglishBackground: Barrett’s esophagus (BE) is an acquired disease defined by the presence of intestinal metaplasia with goblet cells in the distal esophagus. The prevalence of BE has increased dramatically over the last years. Aims: The primary aims of the study were to analyze the characteristics of BE and esophageal adenocarcinoma (EAC) in a Spanish health district during a follow-up period. Methodology: Sociodemographic factors, alcohol consumption and cigarette smoking were analyzed. We also studied the histological behavior and cause of death in each group. Results: In the present study 430 patients were included, 338 with BE and 92 with EAC. Incidence rates have risen from 2.25 and 1.25 per 100,000 inhabitants in 1996 to 6.5 and 4.75 per 100,000 in 2011, respectively. In the EAC group, male gender, age and alcohol consumption were higher in comparison to the BE group, and the overall survival was 23 months. In the BE group, the main causes of death were non-esophageal cancer and cardiovascular disease. Conclusions: The incidence and prevalence rates of AEC and BE have risen over the past years. Risk factors for these conditions were male gender, age and alcohol consumption. Long BE (> 3 cm) is involved in dysplasia progression. AEC diagnosis mainly occurs after neoplasia is detected and, in a few cases, due to a previous BE. Cardiovascular diseases and non-esophageal cancers have been found to be the main cause of death in BE patients.

Aim Esophageal capsule endoscopy is a well tolerated procedure that does not require sedation and has proved its value for the study of the esophagus. The aim of our study was to assess the feasibility, accuracy, safety and acceptability of esophageal capsule endoscopy for the study of gastroesophageal reflux disease and esophageal varices in patients who refused conventional upper gastrointestinal endoscopy. Patients and methods Thirty consecutive examinations performed in 28 patients (15 men/13 women; mean age: 58.5+/-12.4 years; range: 23-87 years) were reviewed. Twenty-five examinations were performed in 23 patients presenting with chronic gastroesophageal reflux disease symptoms and the remaining five were carried out in patients with cirrhosis for screening of esophageal varices. The procedures were done with the new PillCam ESO that harbors two viewing cupules and takes a total of 14 frames/s. Technical data (total recording time, esophageal transit time and Z-line visualization), clinical findings (Savary-Miller grade; presence and characteristics of esophageal varices or portal hypertension gastropathy), and patient's opinion (quality and comfort questionnaire) were analyzed. Results All the patients ingested and excreted the capsule without complications. Two examinations in the gastroesophageal reflux disease group were repeated; one was issued as a follow-up and the other because no images were recorded in the first capsule endoscopy. From the former, only the satisfaction questionnaire was analyzed. Mean total recording time and esophageal transit time were 1224 and 243.79 s, respectively (range: 2-1192 s). Complete study of the Z-line was possible in 23 examinations (23/29; 79.3%). Esophageal erosions were seen in 58.33% (14/24) of the examinations carried out in patients with gastroesophageal reflux disease. Nine out of 14 patients (64.29%) presented with grade I esophagitis and the other five (35.71%) with grade II esophagitis. Among the five patients with cirrhosis, small varices were visualized in one (1/5; 20%), while large varices with red spots were evidenced in the remaining three (3/5; 60%). All four patients showing esophageal varices were found to have portal hypertension gastropathy. In most examinations, patients found the capsule easy to swallow (28/30; 93.33%), asymptomatic (29/30; 96.66%), evaluated the procedure as comfortable (29/30; 96.66%), and would repeat it if necessary (30/30; 100%). Conclusions Esophageal capsule endoscopy is an adequate alternative diagnostic method for the study of gastroesophageal reflux disease and for the screening of esophageal varices in patients refusing to undergo conventional upper gastrointestinal endoscopy.

Objective To assess the effect of a 2-week treatment with dexibuprofen, in comparison with ibuprofen and diclofenac, on pepsinogen plasma concentrations and gastrointestinal mucosa, as well as the correlation of these changes with gastrointestinal mucosal injury. Methods 60 patients with rheumatologic disease in chronic therapy with NSAID, were included. After a 7-day run-in period patients were randomly assigned to receive a 14-day treatment with dexibuprofen (Group A; Day 1 - 3 = 400 mg t.i.d; Day 4 - 14 = 400 mg b.i.d.), ibuprofen (Group B; Day 1 - 3 = 800 mg t.i.d; Day 4 -14 = 800 mg b.i.d.) or diclofenac (Group C; Day 1 - 3 = 50 mg t.i.d; Day 4 - 14 = 50 mg b.i.d.). Upper gastrointestinal endoscopy (Day 15), capsule-endoscopy (Day 16, 7 patients of each group) and determination of pepsinogen plasma concentrations were performed (basal and Day 15). A semiquantitative scale was designed for the assessment of the gastrointestinal mucosa. Results No differences in plasma pepsinogen were found between treatment groups or gastrointestinal injury grades or between basal and post-therapy determinations. Dexibuprofen showed gastroduodenal mucosal injury in fewer patients (42.1%) than was the case with ibuprofen (5%; p = 0.003) and diclofenac (30%; p = N.S.). Dexibuprofen administration was also associated with more patients having no intestinal mucosal damage (42.86% vs. 28.7% in the diclofenac group and 14.29% in the ibuprofen group; p = 0.0175). The rate of clinical adverse events was similar in Groups A, B and C (28%, 38% and 34%). Conclusions Dexibuprofen showed a lower rate of gastroduodenal and intestinal mucosal injury. This effect was not mediated by modifications of plasma pepsinogen levels.

Background and Study Aims: The aim of this study was to assess the safety and usefulness of capsule endoscopy (CE) in pediatric patients with a suspicion of Crohn's disease. Patients and Methods: CE was used in 12 patients (four girls, eight boys; age 12 - 16; weight range 43-87 kg). The indication was a clinical suspicion of Crohn's disease not confirmed with traditional methods. Gastroscopy, colonoscopy, and small-bowel follow-through examinations were carried out in all of the patients, without any diagnostic findings. Ileoscopy was possible in 50% of the patients, and the ileal mucosa and biopsies were normal in all cases. Results: The capsule was easily swallowed by all of the patients. They all excreted the capsule normally, and no complications were observed in any case. CE identified lesions suggestive of Crohn's disease in seven of the 12 (58.3%), and the majority of the lesions were in the ileum. Conclusions: CE is safe in pediatric patients over 12 years of age. The procedure appears to be a very useful diagnostic tool in children with Crohn's disease.

Introduction: Capsule endoscopy (CE) has become a first-line tool for small bowel (SB) examination. However, adverse events (AEs), such as CE retention or aspiration, may occur. The aims of this study were to evaluate incidence, clinical outcomes and therapeutic approaches of CE-related AEs in the largest series published to date. Methods: Data from 5428 procedures performed at 12 institutions between August 2001 and January 2012 were retrospectively analyzed. Baseline patient characteristics; procedure; type, localization and symptoms before/after AEs; previous patency tests performed; therapeutic management and patient´s outcome were recorded. Results: The overall incidence of CE-related AEs was 1.9%: 2.0% for SB, 0.9% for esophageal and 0.5% for colon CE. The incidence of capsule retention was significantly higher than capsule aspiration (1.87% vs. 0.003%; p < 0.05), in patients suffering from inflammatory bowel disease (IBD) than in obscure GI bleeding (OGIB) (3.3% vs. 1.5%; p < 0.05) and in patients with the combination of nausea/vomiting, abdominal pain and distension. The SB was the most frequent localization of retention (88.2%). The use of patency tests -except for Patency© capsule- before CE was not a good predictor for AEs. Most of the patients with AEs developed no or mild symptoms (97%) and were managed by non-surgical methods (64.4%). Conclusions: CE-related AEs are uncommon and difficult to predict by imagiological examinations. SB retention, that is usually asymptomatic, is the most frequent AE. In absence of symptoms, non-surgical management of CE-related AEs is recommended.

Introduction: PillCam© colon capsule endoscopy (CCE) enables the study of colonic diseases in a safe and non-invasive way, although there are aspects that need to be improved. Current methods of bowel preparation lead to discordant rates of adequate cleansing and CCE excretion. Aims: To compare the efficacy of colon cleansing using two different regimes (2L PEG plus ascorbic acid versus 4L PEG alone) for PillCam Colon (C2) capsule endoscopy. Methods: Fifty eight patients included in this prospective study and randomized to: Group A, PEG plus ascorbic acid regimen (n = 28, 12 F/16 M) or group B, PEG alone regimen (n = 30, 14 F/16 M). The degree of cleansing was categorized into "excellent-good" or "fair-poor", according to Leighton's recently published preparation scale. CCE excretion rate and colon cleansing were assessed. Patients underwent to PillCam colon of second generation (C2). Results: Cleansing was considered to be excellent-good in 78 % of cases in group A and in 64 % of cases in group B, with no significant difference between the groups (p = 0.252). Nevertheless, when the grade of cleansing was analyzed in segments, a significant difference was found in the cecum and transverse colon. No differences were observed in the bubble effect between preparations. The excretion rate was 93 % in group A versus 70 % in group B (p = 0.043). Conclusions: These results suggest that a 2L PEG plus ascorbic acid regimen is at least as effective as a 4L PEG regimen. This regimen may be considered an effective alternative which would improve compliance because a smaller volume is required.

Objective Colon capsule endoscopy (CCE) is a new endoscopic technique that is minimally invasive and allows evaluation of the colon mucosa without pain, sedation, and gas insufflation. To date, few studies have investigated the use of CCE in patients with ulcerative colitis (UC). This study compares the ability of CCE and a conventional colonoscopy to assess mucosal disease activity and the extent of inflammatory mucosa in patients with UC. Methods Forty-two patients (27 men, mean age 48.5 years) with known UC and indication for colonoscopy were enrolled in this single-blind, prospective study. All patients underwent CCE, followed by a colonoscopy. The activity and extent of the disease was assessed using Mayo scores and Montreal scores, respectively. Results There was a good correlation between CCE and colonoscopy in disease severity (κ=0.79; 95% confidence interval: 0.62-0.96) and extent of inflammation (κ=0.71; 95% confidence interval: 0.52-0.90) observed. The ability of CCE to assess a broad segment of distal ileum led to a change in the diagnosis of UC to ileocolonic Crohn's disease in three patients. Bowel preparation was considered adequate in 80% of the patients and no serious adverse events related to the CCE procedure or bowel preparation were reported. Conclusion CCE is a safe and useful method for the evaluation of patients with UC. The ability of CCE to assess distal ileum provides an advantage to colonoscopy as CCE can identify patients who have been incorrectly diagnosed with UC, resulting in a change in their diagnosis to Crohn's disease.

Capsule endoscopy is nowadays the diagnostic technique of choice in the study of small bowel pathologies, allowing the non-invasive study of the entire mucosa. This has led, together with new technical advances, to the creation of two new models (PillCam ESO and PillCam Colon) for the study of esophageal and colonic diseases. These two new capsules offer an interesting alternative to conventional endoscopy in the study of the upper and lower digestive tracts, because traditional endoscopy is often unpleasant and uncomfortable for the patient, can be painful, often requires moderate or deep sedation and is not without complications (hemorrhage, perforation, etc.). PillCam Colon is particularly important for its usefulness in the diagnosis of colonic polyps, and is a potentially useful tool in cases of incomplete colonoscopy or in colorectal cancer screening, even more when most patients are reluctant to undergo screening programs due to the said disadvantages of conventional colonoscopy. This article discusses the advantages of capsule endoscopy over conventional endoscopy, its current application possibilities and indications in routine clinical practice. In the various sections of the work, we assess the application of endoscopic capsule in different sections of the digestive tract (esophagus, stomach, and colon) and finally the potential role of panendoscopy with PillCam Colon.

Summary. Measuring von Willebrand factor (VWF)activity is essential for the diagnosis of von Willebranddisease (VWD). The VWF activity is usually assessedbased on measurement of the ristocetin cofactor (VWF:RCo). However, that test is technically challenging andhas high intra- and inter-assay variabilities. A newautomated chemiluminescent immunoassay VWFactivity has recently become commercially available(HemosIL AcuStar von Willebrand Factor RistocetinCofactor Activity). The main objective of this study wasto evaluate this new method and to compare it with theVWF:RCo assay as the reference method. We studied91 samples, 18 healthy volunteers samples and 73samples from patients (VWF:RCo level

Head-on comparative studies of factor IX (FIX) concentrates performed under standardized conditions are rarely conducted regardless of being a valuable instrument guiding health care providers towards better informed and cost-effective decisions. This study is an extension of a multicentre study that assessed the efficacy, safety and pharmacokinetics (PK) of AlphaNine(®) in 25 previously treated patients with severe haemophilia B (FIX:C ≤ 2%). After a washout period ≥ 7 days following the last PK performed with AlphaNine(®) after a dose of 65-75 IU kg(-1) , an identical PK study was performed with BeneFIX(®) on 22 of the same patients. Venous blood samples for analysis were taken at baseline and at 0.25, 0.5, 1, 3, 6, 9, 24, 48, 72 and 74 h post infusion. The outcomes of the comparison of the PK parameters were as follows: Mean (± SD) in vivo recovery (IVR) was 1.3 ± 0.4 IU dL(-1) per IU kg(-1) for AlphaNine(®) and 1.0 ± 0.3 IU dL(-1) per IU kg(-1) for BeneFIX(®) (P < 0.01). Mean terminal half-life, mean residence time, area under the curve, clearance and volume of distribution of BeneFIX(®) were 36.0 ± 12.8 h, 39.3 ± 13.9 h, 1631 ± 467 IU h dL(-1) , 0.046 ± 0.01 dL kg(-1) min(-1) and 1.75 ± 0.52 mL kg(-1) respectively. These values were not significantly different to those observed in AlphaNine(®), although BeneFIX(®) displayed higher than expected IVR values and lower than expected clearance values. In conclusion, AlphaNine(®) showed a comparable half-life, but an IVR significantly higher than that of BeneFIX(®). This dissimilarity may have implications on dosing requirements for on-demand treatment regimes affecting optimal resource allocation.

Therapy of gastric varices (GV) is still challenging. Cyanoacrylate (CYA) injection is the recommended treatment for bleeding GV, but has a known adverse event rate, which could be reduced if EUS is used for guidance. Otherwise, EUS-guided coil application (ECA) may be an alternative.To compare CYA and ECA embolization of feeding GV for feasibility, safety, and applicability.Retrospective analysis of a prospectively maintained database.Multicenter study, tertiary referral centers.Thirty consecutive patients with localized GV who received either CYA injection or ECA were included with follow-up for 6 months after treatment.There were 11 patients in the coil group and 19 patients in the CYA group. The GV obliteration rate was 94.7% CYA versus 90.9% ECA; mean number of endoscopy sessions was 1.4 ± 0.1 (range 1-3). Adverse events occurred in 12 of 30 patients (40%) (CYA, 11/19 [57.9%]; ECA, 1/11 [9.1%]; P.01); only 3 were symptomatic, and an additional 9 (CYA group) had glue embolism on a CT scan but was asymptomatic. No further adverse events occurred during follow-up. Six patients (20%) died unrelated to the procedures or bleeding.Nonrandomized; EUS expertise necessary.EUS-guided therapy for GV by using CYA or ECA is effective in localized GV. ECA required fewer endoscopies and tended to have fewer adverse events compared with CYA injection. Larger comparative studies are needed to prove these data.

Background: adalimumab, a human anti-TNF, is an effective induction and maintenance therapy for patients with moderate to severe Crohn s disease. It seems to be effective in patients with resistance to infliximab, too, though the experience is more limited. Aim: to evaluate the efficacy of adalimumab, in patients with Crohn s disease (CD) and failure to previous treatment with infliximab. Methods: twenty-five patients with CD and failure to previous treatment with infliximab were enrolled; they were treated with 160/80 (24 patients) and 80/40 (1 patient) induction doses. We analyze clinical response to treatment with adalimumab by the Crohn’s disease Activity Index (CDAI) and plasma concentration of C-reactive protein (CRP), steroid sparing and complete fistula closure at week 48. Results: eighteen out of twenty-five patients (72%) achieved clinical remission (CDAI score < 150) at week 24 and 15/25 (60%) patients at week 48. There was a statistically significant difference (p < 0.01) in CRP serum levels from 21 to 8 mg/dl at week 48. Nine out of fifteen patients (60%) treated with corticosteroids were able to discontinue steroids. Three out of eleven patients (27%) with fistulizing Crohn s disease had complete fistula closure after the treatment. Seventy two percent of the patients (18/25) needed to increase adalimumab to weekly dose, in order to maintain clinical response. Five out of twenty-five patients (20%) had adverse events; two of them (8%) with serious adverse events (tuberculous meningitis and abdominal abscess) that forced the withdrawal of treatment. Conclusions: according to these data, adalimumab provides a clinical and analytical improvement in patients with CD and failure to previous therapy with infliximab.

OBJECTIVE To evaluate the type, frequency, and severity of macroscopic small bowel mucosal injury after chronic NSAID intake as assessed by capsule endoscopy (CE), as well as to correlate the severity of gastroduodenal and intestinal damage in these patients. MATERIAL AND METHODS A prospective, endoscopist-blind, controlled trial. Sixteen patients (14F/2M; age: 57.06 +/- 10.16 yrs) with osteoarthritis (OA) on chronic therapy with NSAIDs underwent CE and upper gastrointestinal endoscopy (UGE). Seventeen patients with OA (9F/2M; age: 57.47 +/- 9.82 yrs) who did not take NSAIDs were included as a control group. A scale ranging from 0 to 2 (0 = no lesions, 1-minor = red spots or petechiae, denuded areas and/or 1-5 mucosal breaks; 2-major = > 5 mucosal breaks and/or strictures, or hemorrhage) was designed to assess the severity of small bowel mucosal injuries. RESULTS CE found intestinal lesions in 75% (12/16) of patients in the study group and in 11.76% (2/17) of controls (p < 0.01). Seven out of 16 NSAID consumers (43.75%) and none in the control group (0%) had a major small bowel mucosal injury (p < 0.01). The percentages of patients with grade 1 and 2 gastroduodenopathy in the study group, as assessed by UGE, were 37.14 and 23.81%, respectively. There was no significant difference in the rate of major enteropathy between patients with none or minor gastroduodenal injury, and those with major gastroduodenopathy (43.75 vs. 40%; p = N.S.). CONCLUSIONS Chronic NSAID intake is associated with a high rate of small bowel mucosal injuries. Our data have failed to demonstrate a relationship between the severity of gastroduodenal and intestinal injury.

Small bowel strictures can be missed by current diagnostic methods. The Patency capsule is a new non-endoscopic dissolvable capsule which has as an objective of checking the patency of digestive tract, in a non-invasive manner. The available clinical trials have demonstrated that the Patency© capsule is a good tool for assessment of the functional patency of the small bowel, and it allows identification of those patients who can safely undergo a capsule endoscopy, despite clinical and radiographic evidence of small-bowel obstruction. Some cases of intestinal occlusion have been reported with the Patency© capsule, four of them needed surgery. So, a new capsule with two timer plugs (Agile© capsule) has been recently developed in order to minimize the risk of occlusion. This new device stars its dissolution process earlier (30 h after ingestion) and its two timer plugs have been designed to begin the disintegration even when the device is blocked in a tight stricture.