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.