Is ERCP still the elective primary biliary drainage technique in patients with malignant distal biliary obstruction? Response to Garcia-Cano et al.

We have read the letter from García-Cano et al. regarding our Editorial and are very grateful for the response as it contributes to deepening the debate we aim to generate on the topic. We are aware that changing a paradigm is always difficult, takes years, and requires publication of good quality studies. However, the way to progress in medicine and provide the best for patients involves questioning existing paradigms and considering the possibility of changing them. Currently, the outcomes of endoscopic ultrasonography guided transmural biliary drainage (EUS-TBD) have been progressively improving and the rate of adverse events (AE) has considerably decreased. The data currently available suggest that primary EUS-TBD in a specific setting is not inferior to ERCP drainage and may even entail a lower rate of AE.

Is ERCP still the elective primary biliary drainage technique in patients with malignant distal biliary obstruction?

Endoscopic retrograde cholangiopancreatography (ERCP) has been established as the first line therapy for the resolution of biliary and pancreatic diseases. The main disadvantage of the procedure is the rate of adverse events, around 10%1. So, despite being a minimally invasive procedure, ERCP has a non-negligible rate of adverse effects (AEs) and secondary mortality.

Ustekinumab en enfermedad de Crohn: efectividad y seguridad en práctica clínica / Ustekinumab in Crohn's disease: effectiveness and safety in clinical practice

INTRODUCCIÓN: Ustekinumab (UST) es un anticuerpo monoclonal frente a IL-12/23 aprobado en España (2017) para tratar el brote moderado/grave de enfermedad de Crohn. OBJETIVO: Evaluar la efectividad y seguridad en práctica clínica real en los pacientes tratados con UST en nuestro centro. MÉTODOS: Estudio prospectivo observacional unicéntrico incluyendo los pacientes que iniciaron UST desde el 1/08/2017 hasta el 28/02/2019 con seguimiento hasta esa fecha. Analizamos respuesta y remisión en semanas 16, 24 y 52, utilizando «Crohn's Disease Activity Index» (respuesta si descenso de 100 puntos y remisión si <150) y la «Valoración Global del especialista» traducción del «Physician's Global Assessment». RESULTADOS: Incluimos 61 pacientes con una mediana de duración de enfermedad de Crohn de 14,6 años (0-36). El 83,6% sin esteroides y el 73,8% sin inmunosupresores asociados. Previamente todos habían recibido anti-TNF y el 14,8%, además, vedolizumab. Observamos buena correlación entre Crohn's Disease Activity Index y Valoración Global del especialista (r = 0,89, p < 0,001). En la semana 16 (n = 45) un 75,6% de respuesta (57,8% remisión), en semana 24 (n = 35) 69,9% respuesta (45,7% remisión) y en semana 52 (n = 12) 75% respuesta (58,3% remisión). No se obtuvieron diferencias estadísticamente significativas en la tasa de respuesta/remisión en semana 16 ni 24 en función del motivo de inicio de UST o el número de biológicos previos. En 2 pacientes se retiró por toxicidad (artralgias/mialgias). CONCLUSIÓN: UST es un fármaco eficaz y seguro en práctica clínica real con altas tasas de remisión clínica en semana 16, 24 y 52 independientemente del orden de biológico utilizado y del motivo de inicio de UST

INTRODUCTION: Ustekinumab (UST) is a monoclonal antibody against IL-12/23 approved in Spain (2017) to treat moderate / severe Crohn's disease. OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice in patients treated with UST in our center. METHODS: This is a prospective observational study including patients who started UST from 08/01/2017 to 02/28/2019 with follow-up up to that date. We analyze response and remission in weeks 16, 24 and 52, using "Crohn's Disease Activity Index" (response if 100 point decrease and remission if <150) and Physician's Global Assessment. RESULTS: We included 61 patients with a median duration of Crohn's disease of 14,6 years (0-36). The 83,6% of patients without steroids and 73,8% without associated immunosuppressors. Previously all patients had received anti-TNF and 14,8%, in addition, vedolizumab. We observed a good correlation between Crohn's Disease Activity Index and Physician's Global Assessment (r = 0,89, p <.001). In week 16 (n = 45) 75,6% response (57,8% remission), in week 24 (n = 35) 69,9% response (45,7% remission) and in week 52 (n = 12) 75% response (58.3% remission). There were no statistically significant differences in the response/remission rates at week 16 or 24 depending on the reason for the onset of UST or the number of previous biologics. In 2 patients it was withdrawn due to toxicity (arthralgia / myalgia). CONCLUSION: UST is an effective and safe treatment in real clinical practice with high rates of clinical remission at week 16, 24 and 52 regardless of the order of biological used and the reason for starting UST

Ustekinumab in Crohn's disease: effectiveness and safety in clinical practice. / Ustekinumab en enfermedad de Crohn: efectividad y seguridad en práctica clínica.

INTRODUCTION: Ustekinumab (UST) is a monoclonal antibody against IL-12/23 approved in Spain (2017) to treat moderate / severe Crohn's disease. OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice in patients treated with UST in our center. METHODS: This is a prospective observational study including patients who started UST from 08/01/2017 to 02/28/2019 with follow-up up to that date. We analyze response and remission in weeks 16, 24 and 52, using "Crohn's Disease Activity Index" (response if 100 point decrease and remission if <150) and Physician's Global Assessment. RESULTS: We included 61 patients with a median duration of Crohn's disease of 14,6 years (0-36). The 83,6% of patients without steroids and 73,8% without associated immunosuppressors. Previously all patients had received anti-TNF and 14,8%, in addition, vedolizumab. We observed a good correlation between Crohn's Disease Activity Index and Physician's Global Assessment (r = 0,89, p <.001). In week 16 (n = 45) 75,6% response (57,8% remission), in week 24 (n = 35) 69,9% response (45,7% remission) and in week 52 (n = 12) 75% response (58.3% remission). There were no statistically significant differences in the response/remission rates at week 16 or 24 depending on the reason for the onset of UST or the number of previous biologics. In 2 patients it was withdrawn due to toxicity (arthralgia / myalgia). CONCLUSION: UST is an effective and safe treatment in real clinical practice with high rates of clinical remission at week 16, 24 and 52 regardless of the order of biological used and the reason for starting UST.

Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions.

BACKGROUND AND AIMS: The Endoscopic Resection Group of the Spanish Society of Endoscopy (GSEED-RE) model and the Australian Colonic Endoscopic Resection (ACER) model were proposed to predict delayed bleeding (DB) after EMR of large superficial colorectal lesions, but neither has been validated. We validated and updated these models. METHODS: A multicenter cohort study was performed in patients with nonpedunculated lesions ≥20 mm removed by EMR. We assessed the discrimination and calibration of the GSEED-RE and ACER models. Difficulty performing EMR was subjectively categorized as low, medium, or high. We created a new model, including factors associated with DB in 3 cohort studies. RESULTS: DB occurred in 45 of 1034 EMRs (4.5%); it was associated with proximal location (odds ratio [OR], 2.84; 95% confidence interval [CI], 1.31-6.16), antiplatelet agents (OR, 2.51; 95% CI, .99-6.34) or anticoagulants (OR, 4.54; 95% CI, 2.14-9.63), difficulty of EMR (OR, 3.23; 95% CI, 1.41-7.40), and comorbidity (OR, 2.11; 95% CI, .99-4.47). The GSEED-RE and ACER models did not accurately predict DB. Re-estimation and recalibration yielded acceptable results (GSEED-RE area under the curve [AUC], .64 [95% CI, .54-.74]; ACER AUC, .65 [95% CI, .57-.73]). We used lesion size, proximal location, comorbidity, and antiplatelet or anticoagulant therapy to generate a new model, the GSEED-RE2, which achieved higher AUC values (.69-.73; 95% CI, .59-.80) and exhibited lower susceptibility to changes among datasets. CONCLUSIONS: The updated GSEED-RE and ACER models achieved acceptable prediction levels of DB. The GSEED-RE2 model may achieve better prediction results and could be used to guide the management of patients after validation by other external groups. (Clinical trial registration number: NCT03050333.).

Hipertensión portal intrahepática por metástasis sinusoidales de carcinoma urotelial / Intrahepatic portal hypertension due to sinusoidal metastasis from urothelial carcinoma

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