[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.

[Is it possible to stop treatment with nucleos(t)ide analogs in patients with e-antigen negative chronic hepatitis B? Experience and new expectations]. / ¿Es posible suspender el tratamiento con antivirales orales en los pacientes con hepatitis crónica B antígeno e negativa? Experiencia y nuevas expectativas.

BACKGROUND: Treatment of HBeAg-negative chronic hepatitis B (CHB) with nucleos(t)ide analogues (NA) is usually indefinite, since the loss of HBsAg, as a criterion for its discontinuation, is a rare event. Recent evidence suggests that discontinuing NA therapy may be feasible in selected patients. OBJECTIVES: To analyze the rate of virological relapse in patients with HBeAg-negative CHB who discontinued treatment with NAs. METHODS: We performed a single-center observational study that included 140 patients with HBsAg-negative CHB. Twenty-two patients, who received only NAs, discontinued treatment for different reasons and were subsequently monitored. All had normal ALT and AST, undetectable DNA and absence of cirrhosis or significant comorbidities before stopping treatment. RESULTS: Twelve patients showed virologic relapse (54.54%). The mean interval between discontinuation and relapse was 6.38 months (± 1.9) (75% relapsed during the first 12 months after discontinuation). Five received adefovir, 1 lamivudine and adefovir, 1 tenofovir and 5 lamivudine alone. The mean treatment duration in this group was 38.5 months (± 4.5). The sustained response group had a higher mean age and longer treatment duration than patients with virologic relapse but these differences were not statistically significant. CONCLUSIONS: The results suggest that NA treatment can be stopped in selected patients with CHB as long as they are not cirrhotic, have completed a minimum period of treatment, have normal ALT and sustained undetectable DNA. These patients should be closely monitored during the first year and then indefinitely.

[Acute hypertrygliceridemic pancreatitis]. / Pancreatitis aguda por hipertrigliceridemia.

Acute hypertriglyceridemic pancreatitis is the third cause of acute pancreatitis in the Western population. There is usually an underlying alteration in lipid metabolism and a secondary factor. Clinical presentation is similar to that of pancreatitis of other etiologies, but the course of acute hypertriglyceridemic pancreatitis seems to be worse and more recurrent. Some laboratory data can be artefacts, leading to diagnostic errors. This is the case of amylase, which can show false low levels. Treatment is based on intense fluidotherapy and analgesia. When there is no response to conservative management, other methods to lower triglyceride levels should be used. Several options are available, such as plasmapheresis, insulin, and heparin. The present article provides a review of the current literature on this entity.

What Is the Value of the Learning Curve in Endoscopic Balloon Dilatation of the Major Papilla?

INTRODUCTION: Endoscopic papillary large balloon dilatation (EPLBD) is an alternative for the treatment of common bile duct (CBD) stones. Existing evidence of factors associated with its outcomes is contradictory. OBJECTIVE: To identify predictors (including the experience of an endoscopist) of success and adverse events in EPLBD. METHODS: We reviewed the first 200 EPLBD with endoscopic sphincterotomy (EST) performed at our center. Demographic, clinical, and anatomic variables were studied, as well as the performance characteristics, correlating them with individual and group experience. RESULTS: Global success was obtained in 87% of cases, and adverse events occurred in 16% of cases. Success was associated with stone size, CBD diameter, and the need to perform mechanical lithotripsy (ML). Despite that adverse events were not univariately associated with any factor, severe adverse events were more likely to occur in stones > 13.5 mm. Multivariate analysis which disclosed success was higher when ML was not required and stones were < 13.5 mm. It also showed that no factor was associated with adverse events or their severity. No differences were found on success or adverse events that could be directly related to experience. CONCLUSIONS: Success of EPLBD-EST is higher in stones < 13.5 mm and when ML is not required. Experience does not appear to play a major role.

Hemorragia digestiva en paciente con hiperplasia de glándulas de Brunner / Digestive tract hemorrhaging in a patient with Brunner's gland hyperplasia

Resumen Objetivo: analizar las características epidemiológicas, bases etiopatogénicas y presentación clínica, así como el diagnóstico y el tratamiento de la hiperplasia de glándulas de Brunner (HGB). Métodos: describir un caso de HGB diagnosticado de forma incidental durante una endoscopia electiva y realizar una revisión de la literatura disponible hasta el momento. Resultados: esta neoformación consiste en una proliferación glandular localizada preferentemente en el duodeno proximal. Su diagnóstico, normalmente realizado mediante biopsia endoscópica, puede asociarse con complicaciones que, aunque infrecuentes, no deben ser subestimadas. Conclusiones: las neoplasias duodenales representan un porcentaje pequeño dentro del total de las que afectan al tracto gastrointestinal. Debido a que el diagnóstico de estas lesiones suele realizarse de forma casual durante una endoscopia programada, el tratamiento deberá basarse en la sintomatología, así como el tamaño de las mismas, de acuerdo con los estándares de tratamiento de cada centro.

Abstract Objective: This study analyzes the epidemiological characteristics, etiological and pathogenic bases, clinical presentation, diagnosis and treatment of Brunner's gland hyperplasia. Methods: We describe a case of Brunner's gland hyperplasia that was diagnosed incidentally during elective endoscopy and review the available literature. Results: This neoplasm consists of glandular proliferation preferentially located in the proximal duodenum. Its diagnosis, normally made by endoscopic biopsy, can be associated with complications that, although infrequent, should not be underestimated. Conclusions: Duodenal neoplasms are a small percentage of those that affect the gastrointestinal tract. Because diagnosis is usually made by chance during a scheduled endoscopy, treatment should be based on the symptoms and size of the lesion according to the treatment standards of each medical center.