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Objetivo: La medida de los resultados percibidos por el paciente en la asistencia de la enfermedad inflamatoria intestinal (EII) adquiere cada vez más importancia. Existe una herramienta sencilla y validada en inglés para este fin: el «IBD-Control». Nuestro objetivo es traducirlo al español, adaptarlo y validarlo.Pacientes y métodos: Se tradujo el IBD-Control, generando el instrumento en español «EII-Control», y se validó prospectivamente. Los pacientes cumplimentaban el EII-Control y otros cuestionarios que servían de comparadores de referencia. El gastroenterólogo realizaba una valoración global de la enfermedad, calculaba índices de actividad y registraba el tratamiento. Un subgrupo de pacientes repitió toda la valoración en una segunda visita. Se analizó también la utilidad de escalas resumidas del EII-Control (el EII-Control-8 y el EII-Control-EVA). Resultados: Se incluyeron 249 pacientes con EII (101 repitieron la segunda visita). Estándares psicométricos del test: consistencia interna: α de Cronbach para EII-Control 0,83 con fuerte correlación entre EII-Control-8 y EII-Control-EVA (r=0,5); reproducibilidad: correlación intraclase 0,70 para EII-Control; validez de constructo: correlaciones de moderadas a fuertes entre EII-Control, EII-Control-8 y EII-Control-EVA frente a comparadores; validez discriminante: p <0,001; sensibilidad al cambio: misma respuesta que índice de calidad de vida. Sensibilidad y especificidad en el punto de corte 14 de 0,696 y 0,903, respectivamente, para determinar el estado quiescente. Conclusiones: El EII-Control es un instrumento válido para medir el control de la EII desde la perspectiva del paciente en nuestro medio y cultura. Su simplicidad lo convierte en una herramienta útil para apoyar la asistencia.(AU)

Objective: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the “IBD-Control”. Our aim is to translate it into Spanish, adapt and validate it. Patients and methods: The IBD-Control was translated into the Spanish instrument “EII-Control” and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. Results: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. Conclusions: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.(AU)

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Introducción: El uso de prótesis esofágicas para el manejo endoscópico de fístulas y perforaciones se ha convertido en un procedimiento habitual. Una de sus limitaciones es su alta tasa de migración. Para resolver esta situación, se ha propuesto el uso de prótesis cubiertas de doble malla.Objetivos: Analizar nuestra experiencia práctica en el empleo de prótesis esofágicas cubiertas de doble malla (PECDM) (modelo Niti S™ DOUBLE™ Esophageal Metal Stent) en pacientes con fístula o perforación esofágica.Material y métodos: Estudio retrospectivo, descriptivo y unicéntrico, donde se incluyen pacientes con diagnóstico de fístula o perforación esofágica, desde noviembre 2010 hasta octubre 2018. Como objetivo primario, se evaluará su eficacia en términos de éxito técnico. Como objetivo secundario, se analizará su perfil de seguridad.Resultados: Se incluyeron inicialmente un total de 31 pacientes, siendo 8 de ellos excluidos por fallecimiento por causas ajenas a la técnica. Se detectó un éxito técnico del 100%, con un éxito primario del 75% tras la recolocación de la prótesis. Entre sus complicaciones, la migración ocurrió en un 21,7% de los pacientes (n=5), resolviéndose vía endoscópica en el 100% de los casos.Conclusiones: Según nuestros hallazgos, las PECDM suponen una alternativa en el tratamiento de fístulas y perforaciones esofágicas, con una alta tasa de éxito en la resolución de fístulas y baja de complicaciones, en contraste con lo expuesto en las series publicadas. En todos los casos, la migración de la prótesis se resolvió mediante recolocación endoscópica, sin requerir nueva prótesis ni cirugía.(AU)

Introduction: The use of esophageal stents for the endoscopic management of esophageal leaks and perforations has become a usual procedure. One of its limitations is its high migration rate. To solve this incovenience, the double-layered covered esophageal stents have become an option.Objectives: To analyse our daily practice according to the usage of double-layered covered esophageal metal stents (DLCEMS) (Niti S™ DOUBLE™ Esophageal Metal Stent Model) among patients diagnosed of esophageal leak or perforation.Methods: Retrospective, descriptive and unicentric study, with inclusion of patients diagnosed of esophageal leak or perforation, from November 2010 until October 2018. The main aim is to evaluate the efficacy of DLCEMS, in terms of primary success and technical success. The secondary aim is to evaluate their (the DLCEMS) safety profile.Results: Thirty-one patients were firstly included. Among those, 8 were excluded due to mortality not related to the procedure. Following stent placement, technical success was reached in 100% of the cases, and primary success, in 75% (n=17). Among the complications, stent migration was present in 21.7% of the patients (n=5), in whom the incident was solved by endoscopic means.Conclusions: According to our findings, DLCEMS represent an alternative for esophageal leak and perforation management, with a high success rate in leak and perforation resolutions and low complication rate, in contrast to the published data. The whole number of migrations were corrected by endoscopic replacement, without the need of a new stent or surgery.(AU)

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OBJECTIVE: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it. PATIENTS AND METHODS: The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. RESULTS: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. CONCLUSIONS: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.

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INTRODUCTION: The use of esophageal stents for the endoscopic management of esophageal leaks and perforations has become a usual procedure. One of its limitations is its high migration rate. To solve this incovenience, the double-layered covered esophageal stents have become an option. OBJECTIVES: To analyse our daily practice according to the usage of double-layered covered esophageal metal stents (DLCEMS) (Niti S™ DOUBLE™ Esophageal Metal Stent Model) among patients diagnosed of esophageal leak or perforation. METHODS: Retrospective, descriptive and unicentric study, with inclusion of patients diagnosed of esophageal leak or perforation, from November 2010 until October 2018. The main aim is to evaluate the efficacy of DLCEMS, in terms of primary success and technical success. The secondary aim is to evaluate their (the DLCEMS) safety profile. RESULTS: Thirty-one patients were firstly included. Among those, 8 were excluded due to mortality not related to the procedure. Following stent placement, technical success was reached in 100% of the cases, and primary success, in 75% (n=17). Among the complications, stent migration was present in 21.7% of the patients (n=5), in whom the incident was solved by endoscopic means. CONCLUSIONS: According to our findings, DLCEMS represent an alternative for esophageal leak and perforation management, with a high success rate in leak and perforation resolutions and low complication rate, in contrast to the published data. The whole number of migrations were corrected by endoscopic replacement, without the need of a new stent or surgery.

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Introducción: Los inhibidores del punto de control inmunitario (immune checkpoint inhibitors [ICI]) son fármacos eficaces en el tratamiento de diversas neoplasias. Sin embargo, se han relacionado con eventos adversos inmunomediados (EAI) gastrointestinales y hepáticos que pueden desencadenar su interrupción temporal o definitiva. Objetivo: Evaluar, en condiciones de práctica real, la eficacia y la toxicidad gastrointestinal y hepática de los ICI en tratamientos oncológicos. Material y métodos: Estudio retrospectivo con inclusión de pacientes con diagnóstico de neoplasia avanzada que habían recibido al menos una dosis de ICI entre mayo de 2015 y septiembre de 2018. Resultados: Se incluyeron 132 pacientes con neoplasia de pulmón no microcítico (65,15%, n=86), melanoma (22,7%, n=30), carcinoma renal (9,09%, n=12) y otros tumores (3%, n=4). Los fármacos empleados fueron nivolumab (n=82), pembrolizumab (n=28), atezolizumab (n=13), durvalumab (n=2), ipilimumab (n=1) y la combinación anti-CTLA-4/PD-1 (n=6). El 38,6% (n=51) desarrollaron EAI, de tipo gastrointestinal en el 12,9% (n=17). De ellos, el 47% (n=8) requirieron esteroides, y un paciente precisó cirugía por perforación intestinal. En el 3,03% (n=4) se objetivaron EAI hepáticos gradoI: el 50% (n=2) requirieron corticoterapia y en un paciente fue preciso interrumpir el tratamiento. Entre los pacientes con tratamiento combinado, el 66,6% (n=4) presentaron EAI gastrointestinales. La incidencia de EAI no se relacionó con la edad, ni con el sexo, ni con la respuesta al fármaco empleado. Conclusiones: Los EAI gastrointestinales figuran entre los más frecuentemente observados en pacientes en tratamiento con ICI. El manejo multidisciplinar y un mayor conocimiento de dichos eventos podrían ayudarnos a reducir su morbilidad, así como las interrupciones del tratamiento.(AU)

Introduction: Immune checkpoint inhibitors (ICIs) are effective agents against several malignancies. However, they are associated with gastrointestinal and liver immune-related adverse events (GI-IrAEs and LI-IrAEs), which can lead to their temporary or permanent discontinuation. Aim: The aim of this study was to evaluate the efficacy and gastrointestinal and liver toxicity of ICIs in oncological treatments in actual clinical practice. Material and methods: Patients with advanced cancer who received at least 1ICI dose between May 2015 and September 2018 were retrospectively assessed. Results: 132 patients with non-small cell lung cancer (65.15%, n=86); melanoma (22.7%, n=30); renal carcinoma (9.09%, n=12); and other tumours (3%, n=4) were included. The treatments administered were nivolumab (n=82), pembrolizumab (n=28), atezolizumab (n=13), durvalumab (n=2), ipilimumab (n=1) and the antiCTLA-4/PD-1 combination (n=6). In total, 51 patients (38.6%) developed IrAEs, 17 (12.9%) of which experienced GI-IrAEs. Of these, 8 (47%) needed steroids and 1patient required surgery due to intestinal perforation. Grade I Li-IrAEs were observed in 4 patients (3.03%): 2 (50%) required corticosteroids and 1 patient had to discontinue treatment. Four patients (66.6%) who received combination therapy experienced GI-IrAEs. IrAE incidence were not associated with age, gender or drug response. Conclusions: GI-IrAEs are one of the most common adverse events in patients receiving ICIs. A multidisciplinary approach and a greater understanding of these events could help to reduce morbidity and therapy discontinuation.(AU)

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INTRODUCTION: Immune checkpoint inhibitors (ICIs) are effective agents against several malignancies. However, they are associated with gastrointestinal and liver immune-related adverse events (GI-IrAEs and LI-IrAEs), which can lead to their temporary or permanent discontinuation. AIM: The aim of this study was to evaluate the efficacy and gastrointestinal and liver toxicity of ICIs in oncological treatments in actual clinical practice. MATERIAL AND METHODS: Patients with advanced cancer who received at least 1ICI dose between May 2015 and September 2018 were retrospectively assessed. RESULTS: 132 patients with non-small cell lung cancer (65.15%, n=86); melanoma (22.7%, n=30); renal carcinoma (9.09%, n=12); and other tumours (3%, n=4) were included. The treatments administered were nivolumab (n=82), pembrolizumab (n=28), atezolizumab (n=13), durvalumab (n=2), ipilimumab (n=1) and the antiCTLA-4/PD-1 combination (n=6). In total, 51 patients (38.6%) developed IrAEs, 17 (12.9%) of which experienced GI-IrAEs. Of these, 8 (47%) needed steroids and 1patient required surgery due to intestinal perforation. Grade I Li-IrAEs were observed in 4 patients (3.03%): 2 (50%) required corticosteroids and 1 patient had to discontinue treatment. Four patients (66.6%) who received combination therapy experienced GI-IrAEs. IrAE incidence were not associated with age, gender or drug response. CONCLUSIONS: GI-IrAEs are one of the most common adverse events in patients receiving ICIs. A multidisciplinary approach and a greater understanding of these events could help to reduce morbidity and therapy discontinuation.

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BACKGROUND: The Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas. AIMS: To compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy. METHOD: Prospective study enrolling H. pylori-positive patients. Omeprazol and a three-in-one formulation of bismuth-metronidazol-tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol-clarithromycin-amoxicillin-metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires. RESULTS: 404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20-90.52) with OCAM and 88.21% (CI95%: 83.09-92.22) with OBMT-3/1 (p = 0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78-94.95) and 96.17% (CI95%: 92.28-98.45) respectively (p = 0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 (p = 0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 (p = 0.109), being longer (12 vs 7 days, p < 0.0001) and more severe (p < 0.0001) with OCAM. CONCLUSIONS: In a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile

ANTECEDENTES: El Consenso de Maastricht V recomienda tetraterapias como tratamiento de primera línea de Helicobacter pylori en áreas con elevada resistencia a claritromicina (CLA). OBJETIVOS: Comparar la eficacia, los efectos secundarios y el cumplimiento terapéutico entre la tetraterapia sin bismuto y la tetraterapia con bismuto. MÉTODO: Estudio prospectivo que incluyó a pacientes con H. pylori. Se prescribió omeprazol y una formulación 3 en uno de bismuto-metronidazol-tetraciclina (OBMT-3/1) durante 10 días, o una combinación de omeprazol-claritromicina-amoxicilina-metronidazol (OCAM) durante 14 días. El resultado de la erradicación se evaluó mediante una prueba de aliento con urea o histología. Los efectos secundarios y el cumplimiento terapéutico se registraron durante el período de tratamiento empleando cuestionarios específicos. RESULTADOS: Se incluyeron 404 pacientes (mediana de edad de 53 años; un 62,87% de mujeres). El resultado de la prueba posterior al tratamiento estuvo disponible en 382 pacientes (183 con OCAM, 199 con OBMT-3/1). Las tasas de erradicación fueron del 85,94% (IC 95%: 80,20-90,52) con OCAM y del 88,21% (IC 95%: 83,09-92,22) con OBMT-3/1 (p = 0,595) en el análisis por intención de tratar, mientras que en el análisis por protocolo fueron del 91,12% (IC 95%: 85,78-94,95) y del 96,17% (IC 95%: 92,28-98,45), respectivamente (p = 0,083). El cumplimiento terapéutico superior al 90% fue del 91,35% con OCAM y del 92,04% con OBMT-3/1 (p = 0,951). Se observaron efectos secundarios en el 94,02% de los pacientes tratados con OCAM y en el 88,89% de los tratados con OBMT-3/1 (p = 0,109), y fueron más prolongados (12 frente a 7 días, p < 0,0001) y más graves (p < 0,0001) con OCAM. CONCLUSIONES: En un área con elevada resistencia a la CLA no se observan diferencias entre OBMT-3/1 y OCAM en la erradicación de H. pylori ni en las tasas de cumplimiento, pero OBMT-3/1 presenta un perfil de seguridad superior

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BACKGROUND: The Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas. AIMS: To compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy. METHOD: Prospective study enrolling H. pylori-positive patients. Omeprazol and a three-in-one formulation of bismuth-metronidazol-tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol-clarithromycin-amoxicillin-metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires. RESULTS: 404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20-90.52) with OCAM and 88.21% (CI95%: 83.09-92.22) with OBMT-3/1 (p=0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78-94.95) and 96.17% (CI95%: 92.28-98.45) respectively (p=0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 (p=0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 (p=0.109), being longer (12 vs 7 days, p<0.0001) and more severe (p<0.0001) with OCAM. CONCLUSIONS: In a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile.

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