A clinical trial comparing propofol versus propofol plus midazolam in diagnostic endoscopy of patients with a low anesthetic risk.

BACKGROUND AND OBJECTIVES: propofol and midazolam are two of the most commonly used sedatives in upper gastrointestinal endoscopy (UGE). The objective of this study was to evaluate these two sedation regimens administered to patients who underwent an UGE with regard to security, efficiency, quality of exploration and patient response. PATIENTS AND METHODS: a prospective, randomized and double-blind study was performed which included 83 patients between 18 and 80 years of age of a low anesthetic risk (ASA - American Society of Anesthesiologists- I-II) who underwent a diagnostic UGE. Patients were randomized to receive sedation with either placebo plus propofol (group A) or midazolam plus propofol (group B). RESULTS: in group A, 42 patients received a placebo bolus (saline solution) and on average up to 115 mg of propofol in boluses of 20 mg. In group B, 41 patients received 3 mg of midazolam and an average of up to 83 mg of propofol in boluses of 20 mg. There were no significant differences in the adverse effects observed in either group and all adverse events were treated conservatively. The patients in group B (midazolam plus propofol) entered the desired sedated state more quickly with no variation in the overall time of the exploration. The quality of the endoscopic evaluation was similar in both groups and the patients were equally satisfied regardless of the sedatives they received. CONCLUSIONS: the use of midazolam plus propofol as a sedative does not affect the overall exploration time, a lower dose of propofol can be used and it is as safe as administering propofol as a monotherapy while providing the same level of both exploration quality and patient approval.

Risk factors for tuberculosis in inflammatory bowel disease: anti-tumor necrosis factor and hospitalization.

AIMS: To determine risk factors for active tuberculosis in patients with inflammatory bowel diseases. METHODS: Retrospective, case-control study at 4 referral hospitals in Spain. Cases developed tuberculosis after a diagnosis of inflammatory bowel disease. Controls were inflammatory bowel disease patients who did not develop tuberculosis. For each case, we randomly selected 3 controls matched for sex, age (within 5 years) and time of inflammatory bowel disease diagnosis (within 3 years). Inflammatory bowel disease characteristics, candidate risk factors for tuberculosis and information about the tuberculosis episode were recorded. Multivariate analysis and a Chi-squared automatic interaction detector were used. RESULTS: Thirty-four cases and 102 controls were included. Nine of the 34 cases developed active tuberculosis between 1989 and 1999, and 25 became ill between 2000 and 2012. Multivariate regression showed an association between active tuberculosis and anti-TNF (tumor necrosis factor) therapy in the previous 12 months (OR 7.45; 95% CI, 2.39-23.12; p = .001); hospitalization in the previous 6 months (OR 4.38; 95% CI, 1.18-16.20; p = .027); and albumin levels (OR 0.88; 95% CI, 0.81-0.95; p = .001). The median time between the start of biologic therapy and the onset of active tuberculosis was 13 (interquartile range, 1-58) months. Tuberculosis developed after a year of anti-TNF therapy in 53%, and late reactivation occurred in at least 3 of 8 patients. CONCLUSIONS: The main risks factors for developing tuberculosis were anti-TNF therapy and hospitalization. Over half the cases related to anti-TNF treatment occurred after a year.

[Efficacy and effectiveness of biologic therapy in inflammatory bowel disease. EFIFECT study]. / Eficacia y efectividad de la terapia biológica en la Enfermedad Inflamatoria Intestinal. Estudio EFIFECT.

INTRODUCTION: Randomized controlled trials provide the best scientific evidence for the efficacy of biological drugs in inflammatory bowel disease (IBD). However, findings obtained from these trials might not be reproducible in clinical practice. This study aimed to estimate the percentage of patients with IBD treated with biologics who would have been eligible for randomized controlled trials, and to compare the theoretical efficacy of biological drugs with their effectiveness in clinical practice. METHODS: We performed a retrospective multicenter study in 375 patients with IBD treated with anti-TNF agents and followed-up for 1 year. The eligibility criteria for the trial were taken from the ACCENT, SONIC, ACT, CLASSIC and CHARM trials. Eligible patients were included in a second analysis to compare results in clinical practice versus those hypothetically obtained if the patient had been included in a trial. RESULTS: Only 45.6% of 375 patients would have been eligible for pivotal trials. One-year clinical benefit (remission or response) was similar for eligible and non-eligible cohorts (68.4% vs. 68.6%, P=.608). The clinical benefit was greater for current clinical practice than for a hypothetical trial situation (68.4% vs. 44.4%, P<.001) in eligible patients. CONCLUSION: More than half of patients with IBD treated with biologic drugs would not be represented in pivotal trials. The effectiveness of anti-TNF drugs in clinical practice exceeds their theoretical efficacy.

[Clinicopathologic features of colonic perineuriomas]. / Características clínico-patológicas de los perineuriomas colónicos.

Intestinal perineuriomas are uncommon tumors of the gastrointestinal tract. In this study, we analyzed the clinicopathologic and immunohistochemical features of nine colonic perineuriomas. Five patients were women and four were men (median age 59.5 years and 64 years, respectively). All lesions were smaller than 1cm and were located intramucosally, mainly in the distal colon. Immunohistochemical techniques for Glut-1, claudin-1 and EMA were especially useful in characterizing these lesions.

Even non-experts identify non-dysplastic lesions in inflammatory bowel disease via chromoendoscopy: results of a screening program in real-life.

Background and study aims Chromoendoscopy with targeted biopsy is the technique of choice for colorectal cancer screening in longstanding inflammatory bowel disease. We aimed to analyze results of a chromoendoscopy screening program and to assess the possibility of identifying low-risk dysplastic lesions by their endoscopic appearance in order to avoid histological analysis. Materials and methods We retrospectively reviewed chromoendoscopies performed between February 2011 and June 2017 in seven Spanish hospitals in a standardized fashion. We analyzed the findings and the diagnostic yield of the Kudo pit pattern for predicting dysplasia. Results A total of 709 chromoendoscopies (569 patients) were reviewed. Median duration of disease was 16.7 years (SD 8.1); 80.4 % had ulcerative colitis. A total of 2025 lesions (3.56 lesions per patient) were found; two hundred and thirty-two lesions were neoplastic (11.5 %) (223 were LGD (96.1 %), eight were HGD (3.4 %), and one was colorectal cancer (0.5 %). The correlation between dysplasia and Kudo pit patterns predictors of dysplasia (≥ III) was low, with an area under the curve of 0.649. Kudo I and II lesions were correctly identified with a high negative predictive value (92 %), even by non-experts. Endoscopic activity, Paris 0-Is classification, and right colon localization were risk factors for dysplasia detection, while rectum or sigmoid localization were protective against dysplasia. Conclusions Chromoendoscopy in the real-life setting detected 11 % of dysplastic lesions with a low correlation with Kudo pit pattern. A high negative predictive value would prevent Kudo I and, probably, Kudo II biopsies in the left colon, reducing procedure time and avoiding complications.

Ensayo clínico comparando propofol versus propofol más midazolam en endoscopia diagnóstica en pacientes de bajo riesgo anestésico / A clinical trial comparing propofol versus propofol plus midazolam in diagnostic endoscopy of patients with a low anesthetic risk

Antecedentes y objetivos: propofol y midazolam son dos de los fármacos más utilizados en la endoscopia digestiva alta (EDA). El objetivo del estudio fue evaluar dos protocolos de sedación utilizando estos fármacos en pacientes sometidos a una EDA en términos de seguridad, eficiencia, calidad de la exploración y aceptación del paciente. Pacientes y métodos: estudio prospectivo, randomizado y a doble ciego, en el que se incluyó a 83 pacientes de 18-80 años, de bajo riesgo anestésico (ASA I-II) sometidos a EDA diagnóstica, aleatorizados a recibir propofol más placebo (grupo A) o midazolam más propofol (grupo B). Resultados: en el grupo A, 42 pacientes recibieron un bolo de placebo (suero salino) y propofol en bolos de 20 mg hasta una media de 115 mg; en el grupo B, 41 pacientes recibieron 3 mg de midazolam y bolos de 20 mg de propofol hasta una media 83 mg. No hubo diferencias significativas en los efectos adversos en ambos grupos y los que se presentaron se trataron de forma conservadora. Los pacientes en el grupo B (midazolam más propofol) alcanzaron de forma más rápida la sedación deseada sin variar el tiempo global de la exploración. La calidad en la evaluación endoscópica fue similar en ambos grupos y los pacientes se sintieron igualmente satisfechos con ambos regímenes de sedación. Conclusiones: la sedación con midazolam más propofol no afecta al tiempo global de la exploración, utiliza menos dosis de propofol, es tan segura como la administración del propofol en monoterapia, proporciona igual calidad de exploración y similar aceptación por los pacientes

Background and objectives: propofol and midazolam are two of the most commonly used sedatives in upper gastrointestinal endoscopy (UGE). The objective of this study was to evaluate these two sedation regimens administered to patients who underwent an UGE with regard to security, efficiency, quality of exploration and patient response. Patients and methods: a prospective, randomized and double-blind study was performed which included 83 patients between 18 and 80 years of age of a low anesthetic risk (ASA - American Society of Anesthesiologists- I-II) who underwent a diagnostic UGE. Patients were randomized to receive sedation with either placebo plus propofol (group A) or midazolam plus propofol (group B). Results: in group A, 42 patients received a placebo bolus (saline solution) and on average up to 115 mg of propofol in boluses of 20 mg. In group B, 41 patients received 3 mg of midazolam and an average of up to 83 mg of propofol in boluses of 20 mg. There were no significant differences in the adverse effects observed in either group and all adverse events were treated conservatively. The patients in group B (midazolam plus propofol) entered the desired sedated state more quickly with no variation in the overall time of the exploration. The quality of the endoscopic evaluation was similar in both groups and the patients were equally satisfied regardless of the sedatives they received. Conclusions: the use of midazolam plus propofol as a sedative does not affect the overall exploration time, a lower dose of propofol can be used and it is as safe as administering propofol as a monotherapy while providing the same level of both exploration quality and patient approval

Risk factors for tuberculosis in inflammatory bowel disease: anti-tumor necrosis factor and hospitalization

Aims: To determine risk factors for active tuberculosis in patients with inflammatory bowel diseases. Methods: Retrospective, case-control study at 4 referral hospitals in Spain. Cases developed tuberculosis after a diagnosis of inflammatory bowel disease. Controls were inflammatory bowel disease patients who did not develop tuberculosis. For each case, we randomly selected 3 controls matched for sex, age (within 5 years) and time of inflammatory bowel disease diagnosis (within 3 years). Inflammatory bowel disease characteristics, candidate risk factors for tuberculosis and information about the tuberculosis episode were recorded. Multivariate analysis and a Chi-squared automatic interaction detector were used. Results: Thirty-four cases and 102 controls were included. Nine of the 34 cases developed active tuberculosis between 1989 and 1999, and 25 became ill between 2000 and 2012. Multivariate regression showed an association between active tuberculosis and anti-TNF (tumor necrosis factor) therapy in the previous 12 months (OR 7.45; 95% CI, 2.39-23.12; p = 0.001); hospitalization in the previous 6 months (OR 4.38; 95% CI, 1.18-16.20; p = 0.027); and albumin levels (OR 0.88; 95% CI, 0.81-0.95; p = 0.001). The median time between the start of biologic therapy and the onset of active tuberculosis was 13 (interquartile range, 1-58) months. Tuberculosis developed after a year of anti-TNF therapy in 53%, and late reactivation occurred in at least 3 of 8 patients. Conclusions: The main risks factors for developing tuberculosis were anti-TNF therapy and hospitalization. Over half the cases related to anti-TNF treatment occurred after a year (AU)

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Eficacia y efectividad de la terapia biológica en la Enfermedad Inflamatoria Intestinal. Estudio EFIFECT / Efficacy and effectiveness of biologic therapy in inflammatory bowel disease. EFIFECT study

INTRODUCCIÓN: Los ensayos clínicos aleatorizados proporcionan la mejor evidencia científica de la eficacia de los fármacos biológicos en la enfermedad inflamatoria intestinal (EII). Sin embargo, los resultados pueden no ser reproducibles en la práctica clínica. Los objetivos de este estudio son analizar el porcentaje de pacientes con EII tratados con fármacos biológicos que habrían podido ser elegidos para un ensayo clínico aleatorizado y comparar la eficacia teórica de los fármacos biológicos con su efectividad en la práctica clínica. MÉTODOS: Realizamos un estudio retrospectivo multicéntrico en 375 pacientes con EII tratados con anti-TNF con un seguimiento de un año. Los criterios de elegibilidad para la condición de ensayo clínico fueron extraídos de los estudios pivotales ACCENT, SONIC, ACT, CLASSIC y CHARM. Los pacientes elegibles fueron incluidos en un segundo análisis para comparar los resultados en la práctica clínica con los obtenidos tras realizar una estimación teórica si el paciente hubiese sido incluido en un estudio pivotal. RESULTADOS: Solo el 45,6% de los 375 pacientes cumplían los criterios de selección para un estudio pivotal. El beneficio clínico al año fue similar entre los pacientes elegibles y no elegibles (68,4% vs 68,6%). El beneficio clínico en los pacientes elegibles fue mayor en la práctica clínica que en la condición hipotética de un ensayo clínico (68,4% vs 44,4%, p < 0,001). CONCLUSIÓN: Más de la mitad de los pacientes con EII tratados con fármacos biológicos no estarían representados en los ensayos pivotales. La efectividad de los fármacos anti-TNF en la práctica clínica es superior a su eficacia teórica

INTRODUCTION: Randomized controlled trials provide the best scientific evidence for the efficacy of biological drugs in inflammatory bowel disease (IBD). However, findings obtained from these trials might not be reproducible in clinical practice. This study aimed to estimate the percentage of patients with IBD treated with biologics who would have been eligible for randomized controlled trials, and to compare the theoretical efficacy of biological drugs with their effectiveness in clinical practice. METHODS: We performed a retrospective multicenter study in 375 patients with IBD treated with anti-TNF agents and followed-up for 1 year. The eligibility criteria for the trial were taken from the ACCENT, SONIC, ACT, CLASSIC and CHARM trials. Eligible patients were included in a second analysis to compare results in clinical practice versus those hypothetically obtained if the patient had been included in a trial. RESULTS: Only 45.6% of 375 patients would have been eligible for pivotal trials. One-year clinical benefit (remission or response) was similar for eligible and non-eligible cohorts (68.4% vs. 68.6%, P=.608). The clinical benefit was greater for current clinical practice than for a hypothetical trial situation (68.4% vs. 44.4%, P<.001) in eligible patients. CONCLUSION: More than half of patients with IBD treated with biologic drugs would not be represented in pivotal trials. The effectiveness of anti-TNF drugs in clinical practice exceeds their theoretical efficacy

Características clínico-patológicas de los perineuriomas colónicos / Clinicopathologic features of colonic perineuriomas

Los perineuriomas intestinales son lesiones poco frecuentes del tracto gastrointestinal. En este estudio presentamos una serie de 9 casos hallados en la mucosa colónica y analizados desde el punto de vista clínico-patológico e inmunohistoquímico. De ellos, 5 fueron mujeres y 4 hombres con edades medias de 59,5 y 64 años, respectivamente. Todas las lesiones eran de un tamaño inferior a 1 cm y tuvieron una localización intramucosa, predominando las situadas en el colon distal. Las técnicas imnunohistoquímicas para Glut-1, claudina-1 y EMA fueron de gran utilidad para determinar la naturaleza de estas lesiones (AU)

Intestinal perineuriomas are uncommon tumors of the gastrointestinal tract. In thisstudy, we analyzed the clinicopathologic and immunohistochemical features of nine colonic perineuriomas. Five patients were women and four were men (median age 59.5 years and64 years, respectively). All lesions were smaller than 1 cm and were located intramucosally, mainly in the distal colon. Immunohistochemical techniques for Glut-1, claudin-1 and EMA were especially useful in characterizing these lesions (AU)