Endoscopy-Related Bleeding and Thromboembolic Events in Patients on Direct Oral Anticoagulants or Vitamin K Antagonists.

BACKGROUND & AIMS: Few prospective studies have assessed the safety of direct oral anticoagulants (DOACs) in elective endoscopy. Our primary aim was to compare the risks of endoscopy-related gastrointestinal bleeding and thromboembolic events in patients on DOACs or vitamin K antagonists (VKAs) in this setting. Secondarily, we examined the impact of the timing of anticoagulant resumption on the risk of delayed bleeding in high-risk therapeutic procedures. METHODS: We conducted a multicenter, prospective, observational study from January 2018 to March 2020 of 1602 patients on oral anticoagulants (1004 on VKAs and 598 on DOACs) undergoing 1874 elective endoscopic procedures. Our primary outcomes were 90-day thromboembolic events and 30-day endoscopy-related gastrointestinal bleeding. The inverse probability of treatment weighting propensity score method was used for baseline covariate adjustment. RESULTS: The 2 groups had similar risks of endoscopy-related gastrointestinal bleeding (VKAs vs DOACs, 6.2% vs 6.7%; adjusted odds ratio [OR], 1.05; 95% CI, 0.67-1.65) and thromboembolic events (VKAs vs DOACs, 1.3% vs 1.5%; adjusted OR, 0.90; 95% CI, 0.34-2.38). In high bleeding risk procedures (n = 747), delayed anticoagulant resumption (> 48 hours or 24-48 hours vs < 24 hours) did not reduce the risk of postprocedural bleeding (10.3%, 9%, and 5.8%, respectively; adjusted P = .43). Hot and cold snare polypectomy were the most frequent high-risk interventions (41.8% and 39.8%, respectively). CONCLUSION: In a prospective study of patients on DOACs or VKAs undergoing elective endoscopy, endoscopy-related bleeding and thromboembolic events showed similar risk. Our study suggests that early anticoagulant resumption is safe in most patients, but more data are needed for advanced high-risk therapeutic procedures.

A multicentric Spanish study on the characteristics and survival of gastric adenocarcinoma under the age of 60 / Estudio multicéntrico español sobre las características y la supervivencia del adenocarcinoma gástrico en pacientes menores de 60 años

Introduction: In Europe, gastric adenocarcinoma (GADC) is commonly regarded as a disease of the elderly. This study aims to assess the proportion, characteristics, and survival of patients diagnosed with GADC under the age of 60. Materials and methods: This is a retrospective, multicentric, and analytical study conducted at four tertiary Spanish hospitals. All patients diagnosed with GADC between 2008 and 2015 were included. Demographic, clinical, endoscopic, histologic, and survival data were retrieved. A multivariate analysis was performed to compare GADC in young (age≤60 years) and elderly patients. Results: A total of 1374 patients with GADC were included. The mean age was 74 years (SD:11.1); 62.2% were males. There were 177 patients under the age of 60 (12.9%, 95% CI: 11.2-14.8%). GADC was frequently encountered as a metastatic disease in both young and elderly patients (Stage IV: 45.7% and 41%, respectively). In the multivariate analysis, alcohol abuse, ASA functional status I-II, diffuse subtype, neoadjuvant, and palliative therapy were independently associated (P<0.05) with age ≤60 years. No differences were found in 2-year survival (GADC ≤60: 39% vs. 35%, P=0.45). Curative-intent surgery, TNM stage I-II, body mass index<30kg/m2, and better functional status at diagnosis were independent predictors of survival in GADC under the age of 60. Conclusions: One out of eight cases of GADC were diagnosed under the age of 60. Metastatic disease was frequent at diagnosis and overall survival was poor regardless of age. Factors associated with localized disease correlated with improved survival in younger patients. Our results underline the need for early diagnosis strategies in our country

Introducción: En Europa, el adenocarcinoma gástrico (ADCG) afecta principalmente a pacientes de edad avanzada. Este estudio tiene como objetivo evaluar la proporción, las características y la supervivencia de los pacientes diagnosticados de ADCG menores de 60 años. Material y métodos: Estudio retrospectivo, multicéntrico y analítico realizado en 4 hospitales terciarios españoles. Se incluyeron todos los pacientes diagnosticados con ADCG entre los años 2008-2015. Se recogieron datos demográficos, clínicos, endoscópicos, histológicos y de supervivencia. Se realizó un análisis multivariante para comparar el ADCG en pacientes jóvenes (edad≤60 años) y de edad avanzada. Resultados: Se incluyeron un total de 1.374 pacientes con ADCG. La edad media fue de 74 años (DE: 11,1), el 62,2% varones. Ciento setenta y siete pacientes tenían menos de 60 años (12,9%, IC 95%: 11,2-14,8%). El ADCG se diagnosticó con frecuencia como enfermedad metastásica en pacientes jóvenes y ancianos (estadio IV: 45,7 y 41%, respectivamente). En el análisis multivariante, el abuso de alcohol, la clase funcional ASA I-II, el subtipo difuso, el tratamiento neoadyuvante y el tratamiento paliativo se asociaron de forma independiente (p<0,05) con una edad ≤60 años. No se encontraron diferencias en la supervivencia a 2 años (ADCG≤60: 39 vs. 35%; p=0,45). La cirugía con intención curativa, el estadio TNM I-II, el índice de masa corporal <30kg/m2 y un mejor estado funcional al diagnóstico fueron factores predictivos independientes de supervivencia en el subgrupo de pacientes menores de 60 años. Conclusiones: Uno de cada 8 casos de ADCG se diagnosticaron por debajo de los 60 años. Independientemente de la edad, la presencia de metástasis al diagnóstico fue frecuente y la supervivencia global baja. Los factores asociados a enfermedad localizada se correlacionaron con una mejor supervivencia en pacientes más jóvenes. Nuestros resultados apoyan la necesidad de implementar estrategias de diagnóstico temprano en nuestro país

A multicentric Spanish study on the characteristics and survival of gastric adenocarcinoma under the age of 60.

INTRODUCTION: In Europe, gastric adenocarcinoma (GADC) is commonly regarded as a disease of the elderly. This study aims to assess the proportion, characteristics, and survival of patients diagnosed with GADC under the age of 60. MATERIALS AND METHODS: This is a retrospective, multicentric, and analytical study conducted at four tertiary Spanish hospitals. All patients diagnosed with GADC between 2008 and 2015 were included. Demographic, clinical, endoscopic, histologic, and survival data were retrieved. A multivariate analysis was performed to compare GADC in young (age≤60 years) and elderly patients. RESULTS: A total of 1374 patients with GADC were included. The mean age was 74 years (SD:11.1); 62.2% were males. There were 177 patients under the age of 60 (12.9%, 95% CI: 11.2-14.8%). GADC was frequently encountered as a metastatic disease in both young and elderly patients (Stage IV: 45.7% and 41%, respectively). In the multivariate analysis, alcohol abuse, ASA functional status I-II, diffuse subtype, neoadjuvant, and palliative therapy were independently associated (P<0.05) with age ≤60 years. No differences were found in 2-year survival (GADC ≤60: 39% vs. 35%, P=0.45). Curative-intent surgery, TNM stage I-II, body mass index<30kg/m2, and better functional status at diagnosis were independent predictors of survival in GADC under the age of 60. CONCLUSIONS: One out of eight cases of GADC were diagnosed under the age of 60. Metastatic disease was frequent at diagnosis and overall survival was poor regardless of age. Factors associated with localized disease correlated with improved survival in younger patients. Our results underline the need for early diagnosis strategies in our country.

Rate of missed oesophageal cancer at routine endoscopy and survival outcomes: A multicentric cohort study.

Background: Missed oesophageal cancer (MEC) at upper gastrointestinal endoscopy (UGE) is poorly documented. Objective: The objectives of this study were: (1) to assess the rate, predictors and survival of MEC; (2) to compare MEC and non-MEC tumours. Methods: This was a retrospective cohort study conducted at four tertiary centres. Oesophageal cancers (ECs) diagnosed between 2008 and 2015 were included. Patients with a premalignant condition (Barrett, achalasia), prior diagnosis of EC or oesophagogastric junction tumour of gastric origin were excluded. MEC was defined as EC detected within 36 months after negative UGE. Results: 123,395 UGEs were performed during the study period, with 502 ECs being diagnosed (0.4%). A total of 391 ECs were finally included. Overall MEC rate was 6.4% (95% confidence intervals (CI): 4.4-9.3%). The interval between negative and diagnostic UGE was less than 2 years in 84% of the cases. Multivariate analysis showed that a negative endoscopy was associated with proton pump inhibitor (PPI) therapy and less experienced endoscopists. MEC was smaller than non-MEC at diagnosis (25 versus 40 mm, p = 0.021), more often flat or depressed (p = 0.013) and less frequently diagnosed as metastatic disease (p = 0.013). Overall 2-year survival rate was similar for MEC (20%) and non-MEC (24.1%) (p = 0.95). Conclusions: MEC accounted for 6.4% of all ECs and was associated with poor survival. High-quality UGE and awareness of MEC may help to reduce its incidence.

Characteristics and consequences of missed gastric cancer: A multicentric cohort study.

BACKGROUND: Missed gastric cancer (MGC) is poorly documented in Mediterranean populations. AIMS: (1) To assess the rate, predictors and survival of MGC. (2) To compare MGC and non-MGC tumors. METHODS: This is a retrospective-cohort study conducted at four centers. MGC was defined as cancer detected within three years after negative esophagogastroduodenoscopy. Gastric adenocarcinomas diagnosed between 2008-2015 were included. Patients with no follow-up were excluded. RESULTS: During the study period 123,395 esophagogastroduodenoscopies were performed, with 1374 gastric cancers being diagnosed (1.1%). A total of 1289 gastric cancers were finally included. The overall rate of MGC was 4.7% (61/1289, 3.7-6%). A negative esophagogastroduodenoscopy in MGC patients was independently associated with PPI therapy (p < 0.001), previous Billroth II anastomosis (p = 0.002), and lack of alarm symptoms (p < 0.001). The most frequent location for MGC was the gastric body(52.4%). MGCs were smaller than non-MGCs (31 vs 41 mm, p = 0.047), more often flat or depressed (p = 0.003) and less likely to be encountered as advanced disease. Overall 2-year survival was similar between MGC (34.1%) and Non-MGC (35.3 %) (p = 0.59). CONCLUSION: MGC accounted for nearly five percent of newly-diagnosed gastric adenocarcinomas. Overall survival was poor and not different between MGC and non-MGC.

Resultados a largo plazo del tratamiento con linaclotida en el síndrome de intestino irritable tipo estreñimiento / Long-term results of linaclotide in the treatment of constipation-type irritable bowel syndrome

Antecedentes: el síndrome de intestino irritable tipo estreñimiento (SII-E) es una patología prevalente, compleja y multifactorial que representa un desafío tanto desde el punto de vista diagnóstico como terapéutico. Objetivo: evaluar la efectividad, seguridad y satisfacción de linaclotida en pacientes con SII-E. Métodos: estudio prospectivo, unicéntrico y observacional realizado en pacientes con diagnóstico de SII-E. Los pacientes recibieron tratamiento con linaclotida (Constella(r), Allergan Inc., Irvine, CA), 290 microgramos/24 horas, una cápsula 30 minutos antes del desayuno. La variable primaria de efectividad fue el número de deposiciones por semana. Las variables secundarias incluían el grado de satisfacción y el registro de la frecuencia e intensidad de los síntomas (dolor e hinchazón), medidos mediante una escala visual analógica (EVA) de once niveles (0-10), y recogidas mediante un diario que se entregó al paciente. Resultados: treinta pacientes, todas mujeres, fueron incluidas consecutivamente. La mediana del tiempo de seguimiento fue de 18 meses. La media (deviación estándar [DE]) de deposiciones por semana aumentó desde 0,9 (0,6) al inicio del estudio hasta 4,7 (3,7) al final del mismo (p < 0,0001). Resultados similares fueron observados con el dolor (5,7 [2,3] frente a 3,1 [2,8] al inicio y al final del estudio, respectivamente, p < 0,0001) y con la hinchazón (6,8 [1,6] frente a 2,9 [2,5] al inicio y final del estudio, respectivamente, p < 0,0001). El grado medio (DE) de satisfacción al final del estudio fue 6,7 (3,0). Conclusiones: el tratamiento con linaclotida en pacientes con SII-E en el entorno de la práctica clínica se ha mostrado eficaz y seguro a largo plazo

Background: constipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management. Objective: to evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients. Methods: prospective, single-center and observational study conducted in patients diagnosed with C-IBS. The patients were treated with linaclotide (Constella(r), Allergan Inc., Irvine, CA), once-daily via an oral capsule of 290-µg, 30 minutes before breakfast. The primary effectiveness endpoint was the number of bowel movements per week. The secondary endpoints included treatment satisfaction and changes from baseline in frequency and severity of symptoms (abdominal pain and bloating). This was assessed via an 11-point visual analog scale (VAS) reported by the patients in a daily register. Results: thirty female patients were consecutively included. The median follow-up time was 18 months. The mean (standard deviation [SD]) number of weekly bowel movements significantly increased from 0.9 (0.6) at baseline to 4.7 (3.9) at the end of follow-up, p < 0.0001. Abdominal pain significantly decreased from 5.7 (2.3) at baseline to 3.1 (2.8) at the end of the follow-up period, p < 0.0001. Similarly, bloating significantly decreased from 6.8 (1.6) to 2.9 (2.5) at the beginning and end of the treatment period, respectively, p < 0.0001. The mean (SD) degree of satisfaction at the end of the study was 6.7 (3.0). Conclusions: long-term linaclotide treatment in patients with C-IBS is effective and safe in the clinical setting

Coledocoduodenostomía guiada por ultrasonografía endoscópica ante fallo o imposibilidad de CPRE / Endoscopic ultrasound-guided choledochoduodenostomy after a failed or impossible ERCP

Introducción: el drenaje biliar endoscópico guiado por ultrasonografía (DBUSE) es una alternativa al drenaje biliar percutáneo transhepático (CTPH) ante fallo de la colangiografía retrógrada endoscópica (CPRE). Métodos: descripción retrospectiva de seis casos de drenaje biliar guiado por ultrasonografía endoscópica, mediante coledocoduodenostomía (USE-CDS), así como de sus características clínicas, procedimiento endoscópico, complicaciones y posterior seguimiento. Resultados: todos nuestros casos presentaban obstrucción biliar distal de etiología maligna. En cuatro de los seis pacientes se concluyó el procedimiento con buen drenaje posterior. Registramos dos complicaciones tardías por migración de prótesis, sin muertes relacionadas con el procedimiento. El tiempo medio de seguimiento fue de seis meses. Conclusión: la USE-CDS se plantea como una opción terapéutica válida, no exenta de complicaciones, en casos seleccionados y en manos de un equipo de endoscopistas expertos ante fallos del drenaje por CPRE, y como alternativa al CTPH

Introduction: endoscopic ultrasound-guided biliary drainage (EUS-BD) is an alternative to percutaneous trans-hepatic biliary drainage (PTBD) in cases of failed endoscopic retrograde cholangiopancreatography (ERCP). Methods: this is a retrospective description of six cases of endoscopic ultrasound-guided biliary drainage via choledochoduodenostomy (EUCD), as well as the clinical characteristics, endoscopic procedure, complications and monitoring. Results: all cases had malignant distal biliary obstruction. The procedure was concluded with good drainage in four out of six patients. Two late complications were recorded that were caused by stent migration and there were no deaths related with the procedure. The average monitoring period was six months. Conclusions: EUCD can be considered as a valid therapeutic choice in some selected cases and when performed by a team of expert endoscopists in cases of failed ERCP drainage or as an alternative to PTBD. However, the procedure has some associated complications

Long-term results of linaclotide in the treatment of constipation-type irritable bowel syndrome.

BACKGROUND: constipation-predominant irritable bowel syndrome (C-IBS) is a prevalent, complex and multifactorial disorder that represents a challenge in terms of diagnosis and therapeutic management. OBJECTIVE: to evaluate the effectiveness, safety and treatment satisfaction of linaclotide in C-IBS patients. METHODS: prospective, single-center and observational study conducted in patients diagnosed with C-IBS. The patients were treated with linaclotide (Constella®, Allergan Inc., Irvine, CA), once-daily via an oral capsule of 290-µg, 30 minutes before breakfast. The primary effectiveness endpoint was the number of bowel movements per week. The secondary endpoints included treatment satisfaction and changes from baseline in frequency and severity of symptoms (abdominal pain and bloating). This was assessed via an 11-point visual analog scale (VAS) reported by the patients in a daily register. RESULTS: thirty female patients were consecutively included. The median follow-up time was 18 months. The mean (standard deviation [SD]) number of weekly bowel movements significantly increased from 0.9 (0.6) at baseline to 4.7 (3.9) at the end of follow-up, p < 0.0001. Abdominal pain significantly decreased from 5.7 (2.3) at baseline to 3.1 (2.8) at the end of the follow-up period, p < 0.0001. Similarly, bloating significantly decreased from 6.8 (1.6) to 2.9 (2.5) at the beginning and end of the treatment period, respectively, p < 0.0001. The mean (SD) degree of satisfaction at the end of the study was 6.7 (3.0). CONCLUSIONS: long-term linaclotide treatment in patients with C-IBS is effective and safe in the clinical setting.

Endoscopic ultrasound-guided choledochoduodenostomy after a failed or impossible ERCP.

INTRODUCTION: endoscopic ultrasound-guided biliary drainage (EUS-BD) is an alternative to percutaneous trans-hepatic biliary drainage (PTBD) in cases of failed endoscopic retrograde cholangiopancreatography (ERCP). METHODS: this is a retrospective description of six cases of endoscopic ultrasound-guided biliary drainage via choledochoduodenostomy (EUCD), as well as the clinical characteristics, endoscopic procedure, complications and monitoring. RESULTS: all cases had malignant distal biliary obstruction. The procedure was concluded with good drainage in four out of six patients. Two late complications were recorded that were caused by stent migration and there were no deaths related with the procedure. The average monitoring period was six months. CONCLUSIONS: EUCD can be considered as a valid therapeutic choice in some selected cases and when performed by a team of expert endoscopists in cases of failed ERCP drainage or as an alternative to PTBD. However, the procedure has some associated complications.

Limited effectiveness with a 10-day bismuth-containing quadruple therapy (Pylera® ) in third-line recue treatment for Helicobacter pylori infection. A real-life multicenter study.

BACKGROUND: Helicobacter pylori antibiotic resistance is an increasing problem worldwide. Pylera® may be an option as salvage therapy. AIM: To assess the effectiveness, safety, and tolerance of Pylera® as a third-line in clinical practice. MATERIALS AND METHODS: This was a multicenter, observational, prospective database study in four Spanish hospitals. Consecutive H. pylori-infected individuals treated with Pylera® and a proton-pump inhibitor (PPI) were invited to participate if they had failed to respond to PPI-clarithromycin-amoxicillin as first-line and to levofloxacin-amoxicillin-PPI as second-line therapy. Eradication was tested 4-8 weeks after Pylera® using a C13 -urea breath test. Treatment-related adverse effects (TRAEs) were assessed through a questionnaire and by reviewing databases. A questionnaire on patient satisfaction was completed in the last visit. RESULTS: Of 103 subjects fulfilling the selection criteria, 101 were included in the intention-to-treat (ITT) analysis and 97 in the per-protocol (PP) analysis. A 10 day course was prescribed in all patients. Esomeprazole 40 mg b.i.d. was the most used PPI regimen (ITT=94.1%). Ninety-seven individuals (ITT=96.04%) completed more than 90% of the treatment. Overall eradication rates were ITT=80.2% (95% confidence interval [CI]: 72.3%-88.1%) and PP=84.4% (95% CI: 76.8%-91.8%). One or more TRAEs were experienced by 67.3% (95% CI: 57.7%-75.7%), all mild or moderate. TRAEs and the number of pills were the main complaints. CONCLUSION: In an area of high antibiotic resistance to H. pylori, 10-day Pylera® plus double-dose PPI emerged as an alternative as third-line therapy, although not achieving optimal eradication rates. TRAEs were common but were neither severe nor did they condition compliance.

Pancreatitis aguda secundaria a déficit parcial de multidrug resistance 3 p-glycoprotein / Acute pancreatitis secondary to partial multidrug resistance 3 p-glycoprotein deficit

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Aumento de la incidencia de cáncer colorrectal en la provincia de Salamanca. Comparación de dos periodos: 2004-2006 y 2010-2012 / Increasing incidence of colorectal cancer in the province of Salamanca. Comparison of two periods: 2004-2006 and 2010-2012

Objetivos: comparar incidencia, mortalidad y características epidemiológicas de los pacientes diagnosticados de cáncer colorrectal (CCR) en la provincia de Salamanca entre dos periodos: 2010-2012 y 2004-2006. Métodos: estudio observacional retrospectivo. Incluimos todos los CCR diagnosticados según criterios histopatológicos del 01/01/2004 al 31/12/2006 y del 01/01/2010 al 31/12/2012. Las variables estudiadas fueron género, edad, fecha de diagnóstico y localización del tumor. Se han calculado incidencia acumulada e incidencia específica por grupos de edad comparando los resultados entre periodos. Hemos ajustado las tasas por edad a la población mundial estándar para poder compararla con otras poblaciones. Resultados: detectamos un 38% más de CCR en el periodo de 2010 a 2012 que en el de 2004 a 2006. Las variables (sexo, edad de diagnóstico y localización) han sido similares en ambos grupos. En el periodo de 2010-2012 se realizaron más del doble de colonoscopias que en el de 2004-2006. La mortalidad poblacional por CCR también aumentó, aunque de manera mucho menos importante que la incidencia. Conclusiones: existe un claro aumento de la incidencia del CCR en la provincia de Salamanca entre los años 2004-2006 y 2010-2012 no relacionado con el envejecimiento. El aumento considerable de colonoscopias puede haber sido un factor importante para el aumento en la detección (AU)

Objectives: To compare incidence, mortality and epidemiological characteristics of patients diagnosed with colorectal cancer (CRC) in the province of Salamanca over two different periods: 2010-2012 and 2004-2006. Methods: Retrospective observational study. We include all diagnosed cases of CRC according to histopathological criteria from 01/01/2004 to 31/12/2006 and from 01/01/2010 to 31/12/2012. The studied variables were sex, age, date of diagnosis and tumor location. Cumulative incidence and specific incidence in different age groups were measured and compared between the two periods. The age rates were adjusted to the standard world population so that the results could be compared with those of other populations. Results: We detected 38% more cases of CRC in the 2010-2012 period than in 2004-2006. Variables distribution (sex, age at diagnosis and location) was similar in both groups. More than twice as many colonoscopies were performed in 2010-2012 than in 2004-2006. Population mortality due to CRC also increased, although much less importantly than the incidence of this condition. Conclusions: There has been a clear increase in CRC incidence in the province of Salamanca from 2004-2006 to 2010-2012 which is not related to the ageing of the population. The remarkable increase in colonoscopies may have been an important factor for the increased detection (AU)

Increasing incidence of colorectal cancer in the province of Salamanca. Comparison of two periods: 2004-2006 and 2010-2012.

OBJECTIVES: To compare incidence, mortality and epidemiological characteristics of patients diagnosed with colorectal cancer (CRC) in the province of Salamanca over two different periods: 2010-2012 and 2004-2006. METHODS: Retrospective observational study. We include all diagnosed cases of CRC according to histopathological criteria from 01/01/2004 to 31/12/2006 and from 01/01/2010 to 31/12/2012. The studied variables were sex, age, date of diagnosis and tumor location. Cumulative incidence and specific incidence in different age groups were measured and compared between the two periods. The age rates were adjusted to the standard world population so that the results could be compared with those of other populations. RESULTS: We detected 38% more cases of CRC in the 2010-2012 period than in 2004-2006. Variables distribution (sex, age at diagnosis and location) was similar in both groups. More than twice as many colonoscopies were performed in 2010-2012 than in 2004-2006. Population mortality due to CRC also increased, although much less importantly than the incidence of this condition. CONCLUSIONS: There has been a clear increase in CRC incidence in the province of Salamanca from 2004-2006 to 2010-2012 which is not related to the ageing of the population. The remarkable increase in colonoscopies may have been an important factor for the increased detection.

Melanoma maligno primario esofágico: una causa infrecuente de disfagia / Primary malignant melanoma of the esophagus: A rare cause of dysphagia

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