Suboptimal response to tumor necrosis factor antagonists in inflammatory bowel disease in Latin America: EXPLORE LATAM study / Respuesta subóptima a los antagonistas del factor de necrosis tumoral en la enfermedad inflamatoria intestinal en Latinoamérica: Estudio EXPLORE LATAM

Objective Data on anti-tumor necrosis factor (anti-TNF) treatment and suboptimal response (SOR) among patients with inflammatory bowel diseases (IBD) in Latin America (LATAM) are scarce. This study evaluated the incidence and indicators of SOR to anti-TNF therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) from Argentina, Colombia and Mexico. Patients and methods We performed retrospective analysis of data from LATAM patients of the EXPLORE study (NCT03090139) including adult patients with IBD who initiated anti-TNF therapy between March 2010 to March 2015. The cumulative incidence of SOR to first-line anti-TNF therapy was assessed. A physician survey to assess barriers to anti-TNF therapies was also carried out. Results We included 185 IBD patients (UC/CD: 99/86) treated with first-line anti-TNF from Argentina (38 UC; 40 CD), Colombia (21 UC; 25 CD) and Mexico (40 UC; 21 CD). 36.4% of patients with UC and 46.5% of patients with CD experienced SOR to anti-TNF therapy during the median (interquartile range) observational period: 49.0 months (37.2–60.1) in UC, and 50.0 months (40.9–60.1) in CD. The most common indicator of SOR among patients was augmentation of non-biologic therapy (UC: 41.7%; CD: 35.0%). Affordability and late referral to IBD specialist care centers were the most common barriers to anti-TNF therapies. Conclusions SOR to anti-TNF therapy was common in LATAM IBD patients, where augmentation with non-biologic therapy represented the most frequent indicator of SOR across indications. Our findings contribute to the current evidence on the unmet needs associated with anti-TNF in LATAM (AU)

Objetivo Los datos sobre tratamiento con antagonistas del factor de necrosis tumoral (anti-TNF) y su respuesta subóptima (RSO) en las enfermedades inflamatorias intestinales (EII) en América Latina (LATAM) son escasos. Se evaluaron la incidencia e indicadores de RSO a anti-TNF en pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) de Argentina, Colombia y México. Pacientes y métodos Se realizó un análisis retrospectivo de datos del estudio EXPLORE LATAM (NCT03090139), incluyendo pacientes adultos con EII que iniciaron anti-TNF entre marzo de 2010 a marzo de 2015. Se evaluó la incidencia acumulada de RSO a los anti-TNF en primera línea. Además, se realizó una encuesta a especialistas sobre las barreras del tratamiento con anti-TNF. Resultados Se incluyeron 185 pacientes con EII (CU/EC: 99/86) tratados con anti-TNF en primera línea de Argentina (38 CU; 40 EC), Colombia (21 CU; 25 EC) y México (40 CU; 21 EC); 36,4% de los pacientes con CU y 46,5% de los pacientes con EC experimentaron RSO a anti-TNF durante la mediana (intervalo intercuartílico) de 49 meses (37,2-60,1) en CU y 50 meses (40,9-60,1) en EC. El indicador más común de RSO fue el aumento del tratamiento no biológico (CU: 41,7%; EC: 35,0%). La accesibilidad y la derivación tardía a centros especializados fueron las barreras más comunes para el tratamiento con anti-TNF. Conclusiones La RSO a anti-TNF fue frecuente en pacientes con EII de LATAM, el aumento del tratamiento no biológico representó el indicador más frecuente de RSO. Nuestros hallazgos contribuyen a la evidencia actual sobre las necesidades insatisfechas asociadas a los anti-TNF en LATAM (AU)

Suboptimal response to tumor necrosis factor antagonists in inflammatory bowel disease in Latin America: EXPLORE LATAM study.

OBJECTIVE: Data on anti-tumor necrosis factor (anti-TNF) treatment and suboptimal response (SOR) among patients with inflammatory bowel diseases (IBD) in Latin America (LATAM) are scarce. This study evaluated the incidence and indicators of SOR to anti-TNF therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) from Argentina, Colombia and Mexico. PATIENTS AND METHODS: We performed retrospective analysis of data from LATAM patients of the EXPLORE study (NCT03090139) including adult patients with IBD who initiated anti-TNF therapy between March 2010 to March 2015. The cumulative incidence of SOR to first-line anti-TNF therapy was assessed. A physician survey to assess barriers to anti-TNF therapies was also carried out. RESULTS: We included 185 IBD patients (UC/CD: 99/86) treated with first-line anti-TNF from Argentina (38 UC; 40 CD), Colombia (21 UC; 25 CD) and Mexico (40 UC; 21 CD). 36.4% of patients with UC and 46.5% of patients with CD experienced SOR to anti-TNF therapy during the median (interquartile range) observational period: 49.0 months (37.2-60.1) in UC, and 50.0 months (40.9-60.1) in CD. The most common indicator of SOR among patients was augmentation of non-biologic therapy (UC: 41.7%; CD: 35.0%). Affordability and late referral to IBD specialist care centers were the most common barriers to anti-TNF therapies. CONCLUSIONS: SOR to anti-TNF therapy was common in LATAM IBD patients, where augmentation with non-biologic therapy represented the most frequent indicator of SOR across indications. Our findings contribute to the current evidence on the unmet needs associated with anti-TNF in LATAM.

Lesión de Dieulafoy: reporte de dos casos / Dieulafoy lesion: a report of two cases

Se describen dos casos de lesión de Dieulafoy, la cual es definida como una anormalidad de una arteria grande o arteriola, que conserva su calibre al aproximarse a la mucosa. Esta lesión suele presentarse como sangrado gastrointestinal masivo no doloroso e inestabilidad hemodinámica y puede ser causa de hemorragia gastrointestinal fatal. El diagnóstico definitivo es anatomopatológico aunque con la endoscopia se puede alcanzar una precisión elevada siendo esta última el tratamiento de elección. La enfermedad presentaba una mortalidad cercana al 80% antes de la terapia endoscópica y gracias a esta actualmente se ha reducido al 13%. La experiencia del endoscopista y los recursos disponibles influyen en forma directa con la eficacia en el diagnostico, tratamiento y sobrevida de los pacientes.

Two cases of Dieulafoy lesion, defined as a malformation in a large artery or arteriole that retains its caliber when approaching the mucosa, are described here. This lesion usually causes non-painful massive gastrointestinal bleeding and hemodynamic instability and can cause a fatal gastrointestinal hemorrhage. The definitive diagnosis is pathologic, although a high precision can be achieved by endoscopy, that is the treatment of choice. The disease had a mortality rate near 90% before the endoscopic therapy and, thanks to it, it has currently been reduced to 13%. The endoscopist's experience and the available resources influence directly on the effectiveness of diagnosis, management and survival of patients.

Insertion of fully covered self-expanding metal stents in benign biliary diseases.

INTRODUCTION: Benign biliary diseases are traditionally treated using plastic stents. However, fully covered self-expanding metal stents are currently gaining acceptance for the treatment of these pathologies. OBJECTIVE: To assess the effectiveness and complications associated with the placement of temporary endoscopic fully covered self-expanding metal stents for the treatment of benign biliary diseases. MATERIALS AND METHODS: This was a retrospective and observational study using a prospective database from a tertiary care center from March 2012 to May 2016. Some patients that had a fully covered metal stent due to a benign biliary disease were also included. The indications, resolution, technical success rates and adverse events were documented. RESULTS: 31 patients were included with a total of 34 stents inserted. The indications were as follows: 8 (25%) post cholecystectomy biliary stenoses, 11 (31%) large or multiple choledocholithiasis, 3 (8.3%) biliary fistulas, 2 (6%) post-liver transplant stenoses, 2 (8.3%) papillary stenoses, 2 (6%) perforations and 2 (6%) bleeds. The global resolution success rate of the stents for all pathologies was 88%, this included 87.5% (7/8) in post cholecystectomy stenoses, 73% (8/11) in large choledocholithiasis and 100% for the remaining indications. Thirty-three of 34 stents were removed after an average of 133 days (ranging from 10 to 180 days). No complications were registered. CONCLUSION: Fully covered self-expanding metal stents are an effective and reliable alternative for the resolution of benign biliary diseases.

Heterotopía Gástrica Rectal. Reporte de un Caso / Rectal Gastric Heterotopia. A Case Report

La mucosa gástrica heterotópica es una alteración caracterizada por la presencia de mucosa gástrica fuera del estómago siendo la ubicación más frecuente en esófago. La heterotopía gástrica del recto es un hallazgo infrecuente, con sólo 50 casos reportados hasta el momento, descripta por primera vez en 1939. A continuación, describimos un caso de heterotopía gástrica en recto haciendo una breve actualización de las manifestaciones, posibles etiologías y opciones terapéuticas.

Heterotopic gastric mucosa is an anomaly that is characterized by the appearance of gastric mucosa out of the stomach, usually in the esophagus. The gastric heterotopia in rectum is a rare finding -of which only 50 cases reported so far- that was first described in 1939. Below, we describe a case of gastric heterotopia in rectum briefly updating the manifestations, possible causes and therapeutic options.

Reutilización de materiales de colangiografía endoscópica. Estudio prospectivo de minimización de costos / Reusing materials in endoscopic cholangiography. A prospective study on cost minimization

ANTECEDENTES: la colangiografía endoscópica enfrenta el desafío del control de costos en un área de constantes avances tecnológicos. La reutilización es el uso de un dispositivo médico más veces de las especificadas por el fabricante. Esta práctica se halla precedida por las maniobras de reprocesamiento y amparada por la legislación vigente. OBJETIVOS: cuantificar la reducción en el costo de los insumos y evaluar las complicaciones. Método: estudio prospectivo, descriptivo y análisis sobre minimización de costos comparando la reutilización de dispositivos médicos con el uso único de los mismos. RESULTADOS: durante un período de tres meses se realizaron 144 estudios. Con la estrategia de reutilización, se utilizaron: 9 papilótomos, 12 guías hidrofílica, 3 canastillas de Dormia, 4 balones extractor, 5 balones dilatadores y 2 cuchillos de precorte. Representó un costo total de U$ 10 943 (promedio de costo de materiales por cada estudio: U$ 76). Con la estrategia de uso único se hubieran utilizado: 144 papilótomos, 144 alambres guías, 24 canastillas de Dormia, 20 balones dilatadores, 72 balones extractores y 24 agujas de precorte. Esta estrategia hubiera generado un costo total de U$ 126 280 (promedio por estudio U$ 877). Al comparar los valores entre ambas estrategias observamos una minimización significativa en el costo (p< 0.001). No se registraron complicaciones. Conclusión: Con la estrategia de reutilización de los DM los costos se minimizaron significativamente sin generarse complicaciones

BACKGROUND: cost control is challenging endoscopic cholangiography in an area of constant technological advances. Reusing is using a medical device more times than what was specified by the manufacturer. This practice is preceded by reprocessing maneuvers and protected by the applicable laws. OBJECTIVES: to quantify the cost reduction of supplies and assess the complications. Method: a prospective descriptive study and an analysis of cost minimization by comparing the reuse and the single use of medical devices. Results: 144 studies were conducted during a period of three months. The reuse strategy included: 9 papillotomes, 12 hydrophilic guide wires, 3 Dormia baskets, 4 balloon extraction catheters, 5 balloon dilatation catheters and 2 pre-cut knives. It accounted for a total cost of USD 10,943 (average cost of materials per study: USD 76). The single-use strategy would have included: 144 papillotomes, 144 hydrophilic guide wires, 24 Dormia baskets, 20 balloon extraction catheters, 72 balloon dilatation catheters and 24 pre-cut needle knives. This strategy would have amounted to a total cost of USD 126,280 (average per study: USD 877). By comparing the values of both strategies, a significant minimization is seen in the cost (p< 0.001). No complications were seen. CONCLUSION: the strategy for reusing MD involveda significant minimization of costs without causing any complications.

Early precut is as efficient as pancreatic stent in preventing post-ERCP pancreatitis in high-risk subjects - A randomized study.

BACKGROUND: The most common adverse event of endoscopic retrograde cholangiopancreatography is pancreatitis. Precut sphincterotomy has been regarded as a risk factor. Some authors have stated that early precut may actually reduce post-ERCP pancreatitis risk. However, early precut as a preventive measure has not been compared to other preventive measures, such as pancreatic duct stent placement. AIM: To compare the efficacy of early precut sphincterotomy versus pancreatic duct stent placement in high-risk subjects undergoing endoscopic retrograde cholangiopancreatography for the prevention of post-endoscopic cholangiopancreatography. MATERIALS AND METHODS: This was a single-blinded, randomized trial that took place in two tertiary referral centers in Buenos Aires, from November 2011 to December 2013. ERCP subjects presented at least one of the following risk factors: female sex, age less than 40 years, clinical suspicion of sphincter of Oddi dysfunction, previous pancreatitis, and/or common bile duct diameter of less than 8 mm. Only those who presented a difficult biliary cannulation were randomized into two groups: those who received early precut sphincterotomy and those in whom persistency of biliary cannulation was intended, with subsequent pancreatic duct stent placement after cholangiography was achieved. The incidence of post-ERCP pancreatitis, as well as other adverse events incidence, was compared. RESULTS: Overall, 101 patients were enrolled, 51 in the pancreatic duct stent group and 50 in the early precut group. Pancreatitis rate was similar in both groups (3.92% vs 4%, p NS). In all cases, pancreatitis was classified as mild. There were no deaths registered. CONCLUSION: Early precut was associated with an incidence of adverse events similar to pancreatic duct stent placement.

[Endoscopic ultrasound-guided choledocho-duodenostomy in advanced pancreatic cancer with duodenal obstruction]. / Colédoco-duodenostomía guiada por ecoendoscopía en cáncer de páncreas avanzado con obstrucción duodenal.

Endoscopic retrograde cholangiopancreatography (ERCP) is considered the first-approach for biliary drainage. In cases of ERCP failure, patients are usually referred for percutaneous transhepatic biliary drainage or surgical biliary bypass. In the last decade, the indications of endoscopic ultrasound (EUS) in the management of patients with pancreatic cancer have increased, and numerous cases of EUS-guided biliary drainage have been reported in patients with failures during the ERCP. Our goal is to report a patient with locally advanced pancreatic cancer who presented with painless jaundice and cholestasis with biliary and duodenal obstruction. A EUS-guided choledochoduodenostomy was performed by placement of a self-expanding metal stent.

Colédoco-duodenostomía guiada por ecoendoscopia en cáncer de páncreas avanzado con obstrucción duodenal / Endoscopic ultrasound-guided choledocho-duodenostomy in advanced pancreatic cancer with duodenal obstruction

La colangiopancreatografía retrógrada endoscópica (CPRE) se considera el tratamiento de primera línea para el drenaje biliar en pacientes con cáncer de páncreas. En los casos de fracaso por CPRE, generalmente se realiza un drenaje biliar transparietohepático o una derivación biliar quirúrgica. En la última década, las indicaciones y la utilidad de la ecoendoscopia en pacientes con cáncer de páncreas han ido creciendo, y se han informado numerosos casos de drenajes biliares guiados por ecoendoscopia como una alternativa al drenaje biliar percutáneo o quirúrgico en fracasos en la CPRE. Nuestro objetivo es comunicar un caso con cáncer de páncreas localmente avanzado que se presentó con ictericia indolora y síndrome coledociano con obstrucción biliar y duodenal, en el que se realizó una colédoco-duodenostomía guiada por ecoendoscopia mediante la colocación de una prótesis metálica autoexpandible.

Endoscopic retrograde cholangiopancreatography (ERCP) is considered the first-approach for biliary drainage. In cases of ERCP failure, patients are usually referred for percutaneous transhepatic biliary drainage or surgical biliary bypass. In the last decade, the indications of endoscopic ultrasound (EUS) in the management of patients with pancreatic cancer have increased, and numerous cases of EUS-guided biliary drainage have been reported in patients with failures during the ERCP. Our goal is to report a patient with locally advanced pancreatic cancer who presented with painless jaundice and cholestasis with biliary and duodenal obstruction. A EUS-guided choledochoduodenostomy was performed by placement of a self-expanding metal stent.

[Sphincterotomy plus large balloon dilation versus sphincterotomy alone for the extraction of complex lithiasis: A prospective analysis]. / Esfinterotomía más dilatación con balones de grandes volúmenes versusesfinterotomía en la extracción de litiasis complejas: análisis prospective.

BACKGROUND AND PURPOSE: Mid-size sphincterotomy associated with large balloon dilation is an alternative to wide sphincterotomy to remove complex lithiases. However, which of the two techniques is most effective remains unclear. Hence, we conducted this study to compare both methods prospectively. METHOD: Since January 2012 until March 2014, 133 consecutive patients with complex stones were included. Group A underwent mid-size sphincterotomy associated with large balloon dilation and group B underwent wide sphincterotomy alone. Success rates were assessed for: Extraction of stones, ductal patency rate, the use of mechanical lithotripsy, dose, time and dose per radioscopy area as well as procedure-related complications. RESULTS: Group A comprised 44 patients and group B comprised 69 patients. Overall success rate for extraction was 86.4% in group A and 70% in group B (p = 0.069). In giant lithiasis, effective extraction was 89.3% in group A and 58.6% in group B (p = 0.019). Use of mechanical lithotripsy was 15.9% and 30.4%, respectively (p = 0.142). Total radiotherapy dose was 39.8 mGy vs. 26.2 mGy, respectively (p = 0.134). Complications occurred in 6.8% and 5.5% of the procedures in each group, without significant differences among them (p = 0.856). CONCLUSION: Sphincterotomy plus large balloon dilation is more effective and equally safe than conventional sphincterotomy for the management of giant main bile duct lithiasis.

[Hilar bile duct tumors: Endoscopic or percutaneous drainage? A prospective analysis]. / Tumores hiliares biliares: ¿drenaje endoscópico o percutáneo?Análisis prospective.

BACKGROUND AND OBJECTIVE: Both the endoscopic and the percutaneous approach are widely accepted for the drainage of hilar tumors. Our primary objective was to report on the effectiveness and complications of these procedures. METHODS: Prospective observational analysis of the endoscopic and/or percutaneous management of all hilar tumors treated at a referral hospital from October 2011 until October 2014. Group A included patients treated endoscopically and group B included patients treated with percutaneous drainage. The following variables were assessed: Effective biliary drainage rate, survival time and complications. RESULTS: Group A comprised 40 patients and group B, 22 patients. Overall success rate in achieving effective biliary drainage was 85% in group A and 90.9% in group B (p = 0.78). Five patients required a combined approach. In group A, the rate of effective drainage in patients with Bismuth IV-type tumors was 58.3%, while it was 81.8% in patients in group B (p = 0.44). There was no difference in mean survival between both groups. For group A, complication rate was 11.5%, whereas it was 2.94% for group B (p = 0.41). CONCLUSIONS: Endoscopic and percutaneous biliary drainage are both effective methods for the palliative treatment of patients with hilar tumors. However, for Bismuth IV-type strictures, percutaneous drainage proved to be safer and more effective.

[Quality and competence in endoscopic cholangiography. Towards certainty]. / Calidad y competencia en colangiografía endoscópica. Rumbo a lo seguro.

INTRODUCTION: The American Society of Gastroenterology (ASGE) and the American College of Gastroenterolog (ACG) have established indicators to recognize high-quality studies in endoscopic retrograde cholagiopancreatography (ERCP). The indicators were: a) Pre-procedure: adequate indication, informed consent, assessment of the degree of difficulty of the procedure and antibiotic prophylaxis. b) Intraprocedure: cannulation, choledocholithiasis extraction and stents placement rates. c) Postprocedure: full documentation and complications rates. METHODS: Between October 2010 and October 2012 we performed a retrospective, descriptive, observational and self-evaluative study to assess the compliance with ERCP quality indicators proposed by the ASGE. RESULTS: Preprocedural indicators were evaluated in 734 studies. Cannulation, choledocolithiasis extraction and stents placement under the hiliar bifurcation rates were 96.2%, 95.4% and 100%, respectively. The complication rate was 5.6% and the mortality was 0.27%. The severity of complications was evaluated according to the classification of Masci (30 mild, 7 moderate and 4 severe). CONCLUSIONS: Quality is a basic tool that allows the comparison between our actions and the indicators already predetermined as suitable. The appropriate indication is an indicator to improve. We believe that 12% of registered normal studies could be due to a difficult accessibility to magnetic resonance cholangiography in our health system. Achievement of the internationally validated indicators place us as a high-quality endoscopic cholagiography unit and as a training center with appropriate expertise.