Suboptimal response to tumor necrosis factor antagonists in inflammatory bowel disease in Latin America: EXPLORE LATAM study / Respuesta subóptima a los antagonistas del factor de necrosis tumoral en la enfermedad inflamatoria intestinal en Latinoamérica: Estudio EXPLORE LATAM

Objective Data on anti-tumor necrosis factor (anti-TNF) treatment and suboptimal response (SOR) among patients with inflammatory bowel diseases (IBD) in Latin America (LATAM) are scarce. This study evaluated the incidence and indicators of SOR to anti-TNF therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) from Argentina, Colombia and Mexico. Patients and methods We performed retrospective analysis of data from LATAM patients of the EXPLORE study (NCT03090139) including adult patients with IBD who initiated anti-TNF therapy between March 2010 to March 2015. The cumulative incidence of SOR to first-line anti-TNF therapy was assessed. A physician survey to assess barriers to anti-TNF therapies was also carried out. Results We included 185 IBD patients (UC/CD: 99/86) treated with first-line anti-TNF from Argentina (38 UC; 40 CD), Colombia (21 UC; 25 CD) and Mexico (40 UC; 21 CD). 36.4% of patients with UC and 46.5% of patients with CD experienced SOR to anti-TNF therapy during the median (interquartile range) observational period: 49.0 months (37.2–60.1) in UC, and 50.0 months (40.9–60.1) in CD. The most common indicator of SOR among patients was augmentation of non-biologic therapy (UC: 41.7%; CD: 35.0%). Affordability and late referral to IBD specialist care centers were the most common barriers to anti-TNF therapies. Conclusions SOR to anti-TNF therapy was common in LATAM IBD patients, where augmentation with non-biologic therapy represented the most frequent indicator of SOR across indications. Our findings contribute to the current evidence on the unmet needs associated with anti-TNF in LATAM (AU)

Objetivo Los datos sobre tratamiento con antagonistas del factor de necrosis tumoral (anti-TNF) y su respuesta subóptima (RSO) en las enfermedades inflamatorias intestinales (EII) en América Latina (LATAM) son escasos. Se evaluaron la incidencia e indicadores de RSO a anti-TNF en pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) de Argentina, Colombia y México. Pacientes y métodos Se realizó un análisis retrospectivo de datos del estudio EXPLORE LATAM (NCT03090139), incluyendo pacientes adultos con EII que iniciaron anti-TNF entre marzo de 2010 a marzo de 2015. Se evaluó la incidencia acumulada de RSO a los anti-TNF en primera línea. Además, se realizó una encuesta a especialistas sobre las barreras del tratamiento con anti-TNF. Resultados Se incluyeron 185 pacientes con EII (CU/EC: 99/86) tratados con anti-TNF en primera línea de Argentina (38 CU; 40 EC), Colombia (21 CU; 25 EC) y México (40 CU; 21 EC); 36,4% de los pacientes con CU y 46,5% de los pacientes con EC experimentaron RSO a anti-TNF durante la mediana (intervalo intercuartílico) de 49 meses (37,2-60,1) en CU y 50 meses (40,9-60,1) en EC. El indicador más común de RSO fue el aumento del tratamiento no biológico (CU: 41,7%; EC: 35,0%). La accesibilidad y la derivación tardía a centros especializados fueron las barreras más comunes para el tratamiento con anti-TNF. Conclusiones La RSO a anti-TNF fue frecuente en pacientes con EII de LATAM, el aumento del tratamiento no biológico representó el indicador más frecuente de RSO. Nuestros hallazgos contribuyen a la evidencia actual sobre las necesidades insatisfechas asociadas a los anti-TNF en LATAM (AU)

Suboptimal response to tumor necrosis factor antagonists in inflammatory bowel disease in Latin America: EXPLORE LATAM study.

OBJECTIVE: Data on anti-tumor necrosis factor (anti-TNF) treatment and suboptimal response (SOR) among patients with inflammatory bowel diseases (IBD) in Latin America (LATAM) are scarce. This study evaluated the incidence and indicators of SOR to anti-TNF therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) from Argentina, Colombia and Mexico. PATIENTS AND METHODS: We performed retrospective analysis of data from LATAM patients of the EXPLORE study (NCT03090139) including adult patients with IBD who initiated anti-TNF therapy between March 2010 to March 2015. The cumulative incidence of SOR to first-line anti-TNF therapy was assessed. A physician survey to assess barriers to anti-TNF therapies was also carried out. RESULTS: We included 185 IBD patients (UC/CD: 99/86) treated with first-line anti-TNF from Argentina (38 UC; 40 CD), Colombia (21 UC; 25 CD) and Mexico (40 UC; 21 CD). 36.4% of patients with UC and 46.5% of patients with CD experienced SOR to anti-TNF therapy during the median (interquartile range) observational period: 49.0 months (37.2-60.1) in UC, and 50.0 months (40.9-60.1) in CD. The most common indicator of SOR among patients was augmentation of non-biologic therapy (UC: 41.7%; CD: 35.0%). Affordability and late referral to IBD specialist care centers were the most common barriers to anti-TNF therapies. CONCLUSIONS: SOR to anti-TNF therapy was common in LATAM IBD patients, where augmentation with non-biologic therapy represented the most frequent indicator of SOR across indications. Our findings contribute to the current evidence on the unmet needs associated with anti-TNF in LATAM.

Incidence and prevalence of inflammatory bowel diseases in a population from Buenos Aires, Argentina.

BACKGROUND: Inflammatory bowel diseases (IBD) incidence and prevalence in Latin America have experienced a significant shift in the last decades. There is paucity of IBD epidemiologic data in Argentina. AIM: To determine the incidence and prevalence of IBD between 2018 and 2022 of a population from the city of Buenos Aires. MATERIALS AND METHODS: From January 1st, 2018 to December 31st, 2022, the total population of two healthcare insurances were studied. 'Possible' IBD cases were identified using the following information sources: IBD-unit patient databases; electronic medical record; central laboratory electronic database; histopathology electronic database; pharmacy electronic database. Age-adjusted incidence and prevalence rates for Crohn's disease (CD), ulcerative colitis (UC) and IBD were estimated based on the number of patients compared with the at-risk population and expressed per 100,000 subjects. Trends in IBD incidence and prevalence were estimated as annual percentage changes; we used Poisson regression modeling to calculate significance in these trends over time. RESULTS: Information source analysis rendered 172 possible cases, of which 82 cases of IBD were finally confirmed: 27.16% were CD and 72.84% were UC. Mean age-standardized incidence across the study period for IBD, CD and UC was 11.93 (11.28-12.55), 2.88 (2.65-3.07) and 9.05 (8.83-9.2) respectively. Point prevalence on December 31st, 2022 for IBD, UC and CD was 134 (95%CI 132.3-135.6), 98 (96.95-99.52) and 36 (35.69-36.4) respectively. CONCLUSIONS: We found an incidence and prevalence of IBD in a population from Buenos Aires higher than those previously published in epidemiological studies in Argentina.

Endoscopically Active Ulcerative Colitis Is Associated With Asymptomatic Atherosclerotic Vascular Disease: A Case-Control Study.

BACKGROUND: Chronic inflammation in immune-mediated conditions has been associated with an increased risk in atherosclerotic disease. There is paucity of evidence regarding the prevalence of asymptomatic atherosclerosis in patients with ulcerative colitis (UC) and its association with disease activity. We sought to compare the prevalence of asymptomatic atherosclerotic disease between young patients with UC with and without mucosal healing (MH) and healthy control individuals. METHODS: An observational study was conducted in 2 hospitals in Buenos Aires, Argentina. Patients with UC 18 to 50 years of age with at least 1 previous colonoscopy in the last year were enrolled, along with age- and sex-matched healthy control individuals. Carotid and femoral ultrasound assessments were performed to determine the prevalence of atherosclerotic lesions and abnormal intima-media thickness (IMT). We compared the prevalence of atherosclerotic disease and the prevalence of abnormally increased IMT in at least 1 vascular territory. RESULTS: Sixty patients with UC and 60 healthy control individuals were enrolled. Mean age was 38 years and 53.33% were men. Although the prevalence of atherosclerotic lesions was similar in patients with UC without MH when compared with both patients with UC with MH and control individuals (3.7% vs 0% vs 6.67%; P = .1), we found a significant increase in abnormal IMT in at least 1 vascular territory in UC patients without MH when compared with healthy control individuals (48.15% vs 26.67%; P = .05). CONCLUSIONS: Patients with UC with active mucosal inflammation showed a significantly increased odds of asymptomatic femoral or carotid vascular disease when compared with control individuals.

Young patients with endoscopically active ulcerative colitis showed a significantly higher prevalence of abnormal intima-media thickness when compared with control individuals. Among patients with ulcerative colitis, age, disease duration, and C-reactive protein were associated with increased odds of asymptomatic vascular lesions.

Opportunistic Infections in Patients with Inflammatory Bowel Disease Treated with Advanced Therapies: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

BACKGROUND AND AIMS: Advanced therapies for inflammatory bowel disease [IBD] could potentially lead to a state of immunosuppression with an increased risk of opportunistic infections [OIs]. We aimed to provide an update on the incidence of OIs among adult IBD patients in randomized controlled trials [RCTs] of approved biologics and small-molecule drugs [SMDs]. Also, we aimed to describe OI definitions utilized in RCTs, to ultimately propose a standardized definition. METHODS: Electronic databases were searched from January 1, 1990, until April 16, 2022. Our primary outcome was incidence rate of overall OIs among IBD patients exposed and unexposed to biologics or SMDs. We also describe specific OIs reported in included trials, as well as definitions of OIs within studies when provided. RESULTS: Ninety studies were included. The incidence rates of reported OIs were 0.42 and 0.21 per 100 person-years in patients exposed to advanced therapies and placebo, respectively. This was highest for anti-tumour necrosis factors [0.83 per 100 person-years] and Janus kinase inhibitors [0.55 per 100 person-years] and lowest for anti-integrins and ozanimod. On meta-analysis, no increased risk of OIs was observed. None of the studies provided a detailed definition of OIs, or a comprehensive list of infections considered as OIs. CONCLUSION: Different mechanisms of action may have specific OI profiles. In the absence of a uniform definition of OIs, these estimates are less reliable. We propose a definition to be used in future studies to help provide standardized reporting. When using this definition, we saw significant differences in incidence rates of OIs across mechanisms of action.

IgA Deficiency Is Not Systematically Ruled Out in Patients Undergoing Celiac Disease Testing.

BACKGROUND: Guidelines for celiac disease (CD) testing recommend total serum IgA determination alongside anti-transglutaminase IgA antibodies. It is not well known if lack of serum IgA determination is a common finding in clinical practice. AIM: To determine the prevalence of lack of serum IgA determination among patients screened for celiac disease. MATERIALS AND METHODS: We identified all subjects who underwent serum anti-transglutaminase IgA and/or other CD-related antibodies determination at a single teaching hospital in Buenos Aires from October 2019 to February 2020. Medical records were reviewed to select adult patients who were tested for celiac disease. The primary outcome was the proportion of patients with inadequate testing for celiac disease due to lack of serum IgA determination. We retrieved the following variables from each patient's record: age, gender, body mass index, symptoms present at screening, first-grade family history of CD, history of type-1 diabetes mellitus, autoimmune hypothyroidism, Down's syndrome. RESULTS: Overall, 1122 patients were included for analysis. Lack of serum IgA determination prevalence was 20.49%. Among patients who did have serum IgA determination, the prevalence of IgA deficiency was 5.16%. The following variables were independently associated with a significantly increased odds of serum IgA determination: diarrhea [OR 1.55 (1.01-2.34)] and abdominal pain [OR 2.28 (1.44-3.63)]; higher body mass index [OR 0.91 (0.85-0.98)], osteoporosis [OR 0.49 (0.28-0.89)], hypothyroidism [OR 0.18 (0.07-0.45)], arthralgia/arthritis [OR 0.47 (0.27-0.85)], or testing by endocrinologist [OR 0.46 (0.23-0.91)] and gynecologist [OR 0.14 (0.06-0.31)] were inversely associated. CONCLUSION: IgA deficiency is not systematically ruled out in a relatively high proportion of patients undergoing serological screening of celiac disease.

Enfermedad de whipple e hipertensión pulmonar reversible / Whipple's disease and reversible pulmonary hypertension

Resumen La enfermedad de Whipple es una enfermedad multisistémica crónica, causada por la bacteria Tropherima whipplei. Se han descripto aproximadamente 1200 casos en la literatura. La incidencia mundial se estima en 9.8 casos por millón de personas. Los datos provenientes de Sudamérica y Europa muestran que afecta a varones de mediana edad. Se cree que los factores inmunológicos del huésped son los que influyen en el curso de la infección y no el genotipo del agente. Dado que las características clínicas no suelen ser específicas y el espectro de manifestaciones en órganos individuales puede ser subestimado, el diagnóstico sigue siendo muy difícil. Presentamos un caso confirmado por histopatología con compromiso multisistémico. Consideramos importante su difusión dados los escasos casos documentados en Sudamérica y la relevancia de tener presente la sospecha diagnóstica para el abordaje terapéutico precoz que mejora el pronóstico de esta rara enfermedad.

Abstract Whipple's disease is a chronic mutisystem disease caused by the bacteria Tropherima whipplei. Approximately 1200 cases have been described in the literature. The worldwide incidence is estimated at 9.8 cases per million people. Data from South America and Europe show that it affects middle-aged males. It is believed that host immunological factors rather than agent genotypic traits influence the course of the infection. Since the clinical characteristics are usually nonspecific and the wide spectrum of manifestations in individual organs may be underestimated, the diagnosis remains challenging. We present a case with multisystem compromise confirmed by histopathology. We consider its publication important given the few cases documented in South America and the relevance of bearing in mind the importance of an early diagnosis for a prompt treatment that improves the prognosis of this rare disease.

Resección transmural endoscópica de adenoma colónico residual con fibrosis / Endoscopic full-thickness resection of residual colonic adenoma with fibrosis

Resumen La resección transmural endoscópica es una técnica que permite la resección en bloque de lesiones colónicas en pacientes en los cuales han fracasado los métodos endoscópicos convencionales como la resección mucosa endoscópica o la disección submucosa endoscópica. Presentamos el caso de un hombre de 75 años con antecedentes de adenoma de colon con fibrosis debido a dos intentos previos fallidos de resección endoscópica en otra institución. Realizamos con éxito el procedimiento de resección transmural endoscópica evitando así una cirugía.

Abstract Endoscopic full-thickness resection is a technique that allows in block resection of colonic lesions in patients in whom conventional endoscopic methods such as endoscopic mucosal resection or endoscopic submucosal dissection have failed. We present a case of a 75-year-old man with history of a difficult-to-resect colon adenoma. He had undergone two previous failed attempts of endoscopic mucosal resection due to non-lifting sign in another center. We successfully performed an endoscopic full-thickness resection procedure, avoiding unnecessary surgery.

[Whipple's disease and reversible pulmonary hypertension]. / Enfermedad de Whipple e hipertensión pulmonar reversible.

Whipple's disease is a chronic mutisystem disease caused by the bacteria Tropherima whipplei. Approximately 1200 cases have been described in the literature. The worldwide incidence is estimated at 9.8 cases per million people. Data from South America and Europe show that it affects middle-aged males. It is believed that host immunological factors rather than agent genotypic traits influence the course of the infection. Since the clinical characteristics are usually nonspecific and the wide spectrum of manifestations in individual organs may be underestimated, the diagnosis remains challenging. We present a case with multisystem compromise confirmed by histopathology. We consider its publication important given the few cases documented in South America and the relevance of bearing in mind the importance of an early diagnosis for a prompt treatment that improves the prognosis of this rare disease.

La enfermedad de Whipple es una enfermedad multisistémica crónica, causada por la bacteria Tropherima whipplei. Se han descripto aproximadamente 1200 casos en la literatura. La incidencia mundial se estima en 9.8 casos por millón de personas. Los datos provenientes de Sudamérica y Europa muestran que afecta a varones de mediana edad. Se cree que los factores inmunológicos del huésped son los que influyen en el curso de la infección y no el genotipo del agente. Dado que las características clínicas no suelen ser específicas y el espectro de manifestaciones en órganos individuales puede ser subestimado, el diagnóstico sigue siendo muy difícil. Presentamos un caso confirmado por histopatología con compromiso multisistémico. Consideramos importante su difusión dados los escasos casos documentados en Sudamérica y la relevancia de tener presente la sospecha diagnóstica para el abordaje terapéutico precoz que mejora el pronóstico de esta rara enfermedad.

[Endoscopic full-thickness resection of residual colonic adenoma with fibrosis]. / Resección transmural endoscópica de adenoma colónico residual con fibrosis.

Endoscopic fullthickness resection is a technique that allows in block resection of colonic lesions in patients in whom conventional endoscopic methods such as endoscopic mucosal resection or endoscopic submucosal dissection have failed. We present a case of a 75-year-old man with history of a difficult-to-resect colon adenoma. He had undergone two previous failed attempts of endoscopic mucosal resection due to non-lifting sign in another center. We successfully performed an endoscopic full-thickness resection procedure, avoiding unnecessary surgery.

La resección transmural endoscópica es una técnica que permite la resección en bloque de lesiones colónicas en pacientes en los cuales han fracasado los métodos endoscópicos convencionales como la resección mucosa endoscópica o la disección submucosa endoscópica. Presentamos el caso de un hombre de 75 años con antecedentes de adenoma de colon con fibrosis debido a dos intentos previos fallidos de resección endoscópica en otra institución. Realizamos con éxito el procedimiento de resección transmural endoscópica evitando así una cirugía.

[Endoscopic ultrasound-guided hepaticogastrostomy for treatment of malignant biliary obstruction in patient with Roux-en-Y gastrectomy]. / Hepático-gastrostomía guiada por eco endoscopia en obstrucción biliar maligna y gastrectomía subtotal con reconstrucción en Y de Roux.

Endoscopic retrograde cholangiography with biliary stenting is the generally recognized optimal treatment of malignant biliary obstruction. This procedure, though, is challenging in patients with surgically altered anatomy. Endoscopic ultrasound (EUS) enables tissue sampling by means of fine-needle aspiration and also represents an alternative recourse for biliary drainage in preference to a percutaneous approach. We aimed to report a case in which EUS enabled a definitive diagnosis of the recurrence of oncologic disease and the relief of biliary obstruction in a patient with a surgically altered anatomy.

Treatment Adherence in Inflammatory Bowel Disease Patients from Argentina: A Multicenter Study.

METHODS: A multicenter cross-sectional study involving seven referral centers from three cities of Argentina was undertaken. Patients with a diagnosis of ulcerative colitis (UC), Crohn's disease (CD), or indeterminate colitis (IBDU/IC) were invited to answer an anonymous survey, which included a 5-point Likert scale to evaluate adherence to therapies. Independent variables associated with inadequate adherence were evaluated. RESULTS: Overall, 447 UC/IBDU and 135 CD patients were enrolled. Median age was 37 years (range 21-72); 39.8% were male; median time from diagnosis was 6 years (0.5-35). 91.4% were under treatment with at least one oral medication; 50.3% of patients reported inadequate adherence to oral medications. Patients with UC/IBDU had a lower risk of inadequate adherence when compared to patients with CD (OR 0.57 (0.37-0.87)). 21.8% reported inadequate adherence to biologics; subcutaneous administration was significantly associated with inadequate adherence to biologics (OR 4.8 (1.57-14.66)). CONCLUSION: Inadequate treatment adherence is common among patients with IBD, and potentially modifiable factors were identified.

PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS.

Inflammatory bowel disease comprises two distinct conditions - Crohn's disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.

[Helicobacter pylori infection. Frequency of first-line treatment failure]. / Infección por Helicobacter pylori. Frecuencia del fracaso del tratamiento de primera línea.

Antibiotic resistance may hinder the efficacy of eradication therapy against Helicobacter pylori infection and it has become a major concern worldwide. Due to the relatively scarce evidence published in Argentina on this topic, our aim was to describe factors associated with H. pylori persistence after antibiotic treatment. The therapeutic failure rate was described among 81 patients with H. pylori gastritis treated in our Hospital with a post-treatment urea breath test to determine successful eradication. Mean age was 58 ± 12 and 43.2% were male subjects. H. pylori persistence was observed in 17.3% of subjects. Therapeutic failure was more common among patients receiving clarithromycin + amoxicillin therapy that among those receiving levofloxacin + amoxicillin (25% vs. 6.6%, p = 0.04). The following variables were assessed: age, gender, referral symptoms, smoking, anti-inflammatory use, diabetes, obesity, treatment type and duration. Clarithromycin-based therapy and male gender were associated with infection persistence on univariate analysis [OR 4.2 (1.1-15.6) and 5.2 (1.1-26.4)]. On multivariate analysis, clarithromycin-based was associated with infection persistence [5.38 (1.1-29.5)]. We conclude that clarithromycinbased therapy is significantly associated with treatment failure. This failure may be due to an elevated prevalence of H. pylori resistance to clarithromycin in the population under study and raises the question on the utility of such therapeutic alternative.

La resistencia bacteriana a ciertos antibióticos condiciona el éxito del tratamiento erradicador de la infección gástrica por Helicobacter pylori y es motivo de creciente preocupación a nivel mundial. Dada la escasa evidencia publicada en Argentina sobre este tema, nuestro objetivo fue investigar factores asociados a la persistencia de H. pylori post-tratamiento antibiótico. Se determinó la frecuencia de fracaso terapéutico en 81 pacientes con gastritis por H. pylori tratados en nuestro Servicio y sometidos al estudio de urea en aire espirado para confirmar la erradicación de la infección. La edad promedio fue 58 ± 12 y 43.2% eran hombres. La frecuencia de fracaso terapéutico fue 17.3%. De los dos esquemas más utilizados, la frecuencia de fracaso fue mayor con claritromicina + amoxicilina que con levofloxacina + amoxicilina (25% vs. 6.6%, p=0.04). Como factores de riesgo investigamos las siguientes variables: edad, género, síntomas, tabaquismo, consumo de antiinflamatorios, diabetes, obesidad, tipo y duración de tratamiento. En el análisis univariado, el uso de esquemas con claritromicina y el género masculino se asociaron significativamente a persistencia de la infección [OR 4.2 (1.1-15.6) y 5.2 (1.1-26.4)]. En el análisis multivariado, el uso de esquema con claritromicina permaneció asociado al fracaso terapéutico [OR 5.38 (1.1-29.5)]. Concluimos que la inclusión de claritromicina en el esquema terapéutico para la gastritis por H. pylori se asoció a mayor fracaso terapéutico. Este fracaso es atribuible a alta prevalencia de resistencia de H. pylori a ese antibiótico en la población atendida en nuestro hospital y cuestiona las prácticas habituales de tratamiento en nuestro medio.

Infección por Helicobacter pylori: Frecuencia del fracaso del tratamiento de primera línea / Helicobacter pylori infection. Frequency of first-line treatment failure

La resistencia bacteriana a ciertos antibióticos condiciona el éxito del tratamiento erradicador de la infección gástrica por Helicobacter pylori y es motivo de creciente preocupación a nivel mundial. Dada la escasa evidencia publicada en Argentina sobre este tema, nuestro objetivo fue investigar factores asociados a la persistencia de H. pylori post-tratamiento antibiótico. Se determinó la frecuencia de fracaso terapéutico en 81 pacientes con gastritis por H. pylori tratados en nuestro Servicio y sometidos al estudio de urea en aire espirado para confirmar la erradicación de la infección. La edad promedio fue 58±12 y 43.2% eran hombres. La frecuencia de fracaso terapéutico fue 17.3%. De los dos esquemas más utilizados, la frecuencia de fracaso fue mayor con claritromicina + amoxicilina que con levofloxacina + amoxicilina (25% vs. 6.6%, p=0.04). Como factores de riesgo investigamos las siguientes variables: edad, género, síntomas, tabaquismo, consumo de anti-inflamatorios, diabetes, obesidad, tipo y duración de tratamiento. En el análisis univariado, el uso de esquemas con claritromicina y el género masculino se asociaron significativamente a persistencia de la infección [OR 4.2 (1.1-15.6) y 5.2 (1.1-26.4)]. En el análisis multivariado, el uso de esquema con claritromicina permaneció asociado al fracaso terapéutico [OR 5.38 (1.1-29.5)]. Concluimos que la inclusión de claritromicina en el esquema terapéutico para la gastritis por H. pylori se asoció a mayor fracaso terapéutico. Este fracaso es atribuible a alta prevalencia de resistencia de H. pylori a ese antibiótico en la población atendida en nuestro hospital y cuestiona las prácticas habituales de tratamiento en nuestro medio.

Antibiotic resistance may hinder the efficacy of eradication therapy against Helicobacter pylori infection and it has become a major concern worldwide. Due to the relatively scarce evidence published in Argentina on this topic, our aim was to describe factors associated with H. pylori persistence after antibiotic treatment. The therapeutic failure rate was described among 81 patients with H. pylori gastritis treated in our Hospital with a post-treatment urea breath test to determine successful eradication. Mean age was 58 ± 12 and 43.2% were male subjects. H. pylori persistence was observed in 17.3% of subjects. Therapeutic failure was more common among patients receiving clarithromycin + amoxicillin therapy that among those receiving levofloxacin + amoxicillin (25% vs. 6.6%, p = 0.04). The following variables were assessed: age, gender, referral symptoms, smoking, anti-inflammatory use, diabetes, obesity, treatment type and duration. Clarithromycin-based therapy and male gender were associated with infection persistence on univariate analysis [OR 4.2 (1.1-15.6) and 5.2 (1.1-26.4)]. On multivariate analysis, clarithromycin-based was associated with infection persistence [5.38 (1.1-29.5)]. We conclude that clarithromycin-based therapy is significantly associated with treatment failure. This failure may be due to an elevated prevalence of H. pylori resistance to clarithromycin in the population under study and raises the question on the utility of such therapeutic alternative.

Hepático-gastrostomía guiada por eco endoscopia en obstrucción biliar maligna y gastrectomía subtotal con reconstrucción en Y de Roux / Endoscopic ultrasound-guided hepaticogastrostomy for treatment of malignant biliary obstruction in patient with Roux-en-Y gastrectomy

RESUMEN La colangiopancreatografía retrógrada endoscópica (CPRE) representa el tratamiento de primera línea para el drenaje biliar en pacientes con obstrucción biliar maligna avanzada. Sin embargo, este procedimiento representa un desafío en pacientes con anatomía alterada quirúrgicamente. El ultrasonido endoscópico (USE) permite la toma de muestras de tejido mediante punción aspiración con aguja fina y también representa una alternativa de drenaje biliar al abordaje percutáneo o quirúrgico. Nuestro objetivo es comunicar un caso en el que la ecoendoscopia permitió el diagnóstico definitivo de la recurrencia de la enfermedad oncológica de base y el alivio de la obstrucción biliar en un paciente con anatomía alterada quirúrgicamente.

ABSTRACT Endoscopic retrograde cholangiography with biliary stenting is the generally recognized optimal treatment of malignant biliary obstruction. This procedure, though, is challenging in patients with surgically altered anatomy. Endoscopic ultrasound (EUS) enables tissue sampling by means of fine-needle aspiration and also represents an alternative recourse for biliary drainage in preference to a percutaneous approach. We aimed to report a case in which EUS enabled a definitive diagnosis of the recurrence of oncologic disease and the relief of biliary obstruction in a patient with a surgically altered anatomy.

O uso de placebo no contexto de ensaios clínicos na doença inflamatória intestinal / Placebo use in the context of inflammatory bowel disease clinical trials

ABSTRACT Inflammatory bowel disease comprises two distinct conditions - Crohn's disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.

RESUMO A doença inflamatória intestinal compreende duas condições distintas: a doença de Crohn e a retocolite ulcerativa, que podem ser tratadas com imunomoduladores. Uma proporção não negligenciável desses pacientes necessitará de terapia biológica e, muitos destes em tratamento biológico, experimentarão falha primária ou secundária. Como consequência, ensaios clínicos avaliando novas alternativas terapêuticas estão sendo desenvolvidos. Estes ensaios partilham características comuns, tais como ser controlado com placebo. O uso de placebo em ensaios clínicos é uma questão de intenso debate. Aqueles que apoiam o uso do placebo destacam as vantagens metodológicas que os ensaios controlados com placebo têm. Aqueles contra o uso de placebo argumentam que seria contra os princípios éticos na investigação clínica expor um paciente ao placebo quando uma alternativa terapêutica válida existe. Nesta revisão, resumimos os argumentos existentes a favor e contra o uso de placebo no contexto da pesquisa de doença inflamatória intestinal. Finalmente, sugerimos que é muito provável que em um futuro próximo os ensaios de doença inflamatória intestinal não serão mais controlados com um braço placebo; em vez disso, serão feitos ensaios de não-inferioridade com um comparador ativo.

INCREASED RISK OF SYNCHRONOUS COLORECTAL LESIONS IN PATIENTS REFERRED FOR ENDOSCOPIC MUCOSAL RESECTION OF LATERAL SPREADING TUMORS.

BACKGROUND: Endoscopic mucosal resection is one of the most frequent therapeutic alternatives for large colorectal lateral spreading tumors. There are few data on the prevalence of synchronous lesions on these patients. OBJECTIVE: To describe the prevalence of synchronous colorectal lesions in patients referred for endoscopic mucosal resection of lateral spreading tumors >20 mm. METHODS: We reviewed the endoscopic database of our Department and identified adult patients who were referred for the resection of a colorectal lateral spreading tumor >20 mm and had a diagnostic colonoscopy performed up to six months before. The proportion of patients with at least one synchronous lesion was estimated. The following features were compared between patients with and without synchronous lesions: age, gender, bowel preparation quality and cecal intubation on index colonoscopy and therapeutic colonoscopy, serrated adenoma as index lesion. RESULTS: From December 2016 to November 2017, we identified 70 patients who fulfilled inclusion criteria. Median size of lesions was 25 mm (20-45). Eighty percent were located in the right colon and 35.71% were serrated adenomas. Synchronous lesion rate was 38.57%. Bowel preparation quality was similar in both groups when comparing both index and therapeutic colonoscopies. Patients with synchronous lesions had a higher proportion of serrated adenoma as index lesion than patients without synchronous lesions [51.85% vs 25.58%, OR 3.13 (1.13-8.68), P=0.03]. CONCLUSION: We found a high prevalence of synchronous lesions among patients with a large colorectal lateral spreading tumor. This risk seems to be increased if index lesions are serrated adenomas.

[Refractory colitis by Clostridium difficile treated with fecal microbiota transplant]. / Colitis refractaria por Clostridium difficile tratada con trasplante de microbiota fecal.

Clostridium difficile infection is an increasingly recognized cause of diarrhea in inpatients, frequently associated to high mortality. Vancomycin is the treatment of choice for all Clostridium difficile- associated diarrheas, with different degrees of severity. However, some patients develop refractory forms to that treatment and there are no alternative antibiotic schemes recommended for these cases. Fecal microbiota transplantation has been shown to be successful in a series of cases of severe diarrhea associated with this organism. We present a case of refractory C. difficile infection successfully treated with fecal microbiota transplantation.

La diarrea por Clostridium difficile es reconocida de manera creciente en pacientes hospitalizados y se asocia con alta mortalidad. La vancomicina por vía enteral es el tratamiento antibiótico recomendado para las diferentes formas, incluso las más graves. Sin embargo, un grupo pequeño de pacientes desarrolla formas refractarias a ese tratamiento y no existen esquemas antibióticos alternativos recomendados para estos casos. El trasplante de microbiota fecal ha demostrado ser exitoso en una serie de casos de diarrea grave asociada a este microorganismo. Presentamos un caso de diarrea refractaria por C. difficile que fue tratada con éxito con una infusión de microbiota fecal.