Real-world experience of vedolizumab use in Colombian patients with inflammatory bowel disease-EXVEDOCOL.

BACKGROUND: Real-world studies about the effectiveness and safety of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD) in Latin America are scarce. Our study describes the effectiveness and safety of VDZ in Colombian patients with IBD. METHODS: EXVEDOCOL (EXperience of VEDOlizumab in COLombia) was a retrospective, multicenter, observational study. Adults with IBD receiving a first dose of VDZ between July 2016 and October 2018 were included. The co-primary outcomes clinical response, and remission, were determined at week 14 and last visit during the maintenance phase (LVMP). The secondary outcomes, deep remission and loss of response were recorded at LVMP. RESULTS: Thirty-one patients (25 ulcerative colitis (UC), 6 Crohn's disease (CD)) were included. At week 14, clinical response was achieved by 87.1% (27/31) of the patients treated with VDZ, while loss of response was reported in 6.7% (2/30). The remission rate at week 14 was 65.5% (19/29) and 75.9% (22/29) at LVMP. Prior anti-TNF exposure was reported in 61.3% (19 patients) of whom 84.2% (16/19) achieved clinical response at week 14 and 89.5% (17/19) at LVMP. For anti-TNF naïve patients, clinical response was recorded in 91.7% (11/12) at week 14 and 100% (12/12) at LVMP. CONCLUSIONS: High clinical remission rates and safety profile highlight VDZ as a valuable treatment option for IBD patients. Anti-TNF naïve patients may derive greater benefit from therapy. Studies with larger cohorts could confirm these findings.

Guía de práctica clínica para el diagnóstico y tratamiento del estreñimiento crónico funcional en población adulta / Clinical Practice Guideline for the Diagnosis and Management of Adult Patients with Functional Chronic Constipation

Objetivo: diseñar una guía de práctica clínica para orientar el diagnóstico, y establecer la clasificación y el tratamiento farmacológico y no farmacológico en los pacientes adultos con estreñimiento crónico funcional en Colombia. Materiales y métodos: el grupo desarrollador de la presente guía estuvo conformado por un equipo multidisciplinario con apoyo de la Asociación Colombiana de Gastroenterología, el Grupo Cochrane ITS y el Instituto de Investigaciones Clínicas de la Universidad Nacional de Colombia. Se desarrollaron preguntas clínicas relevantes y se realizó la búsqueda de guías nacionales e internacionales en bases de datos especializadas. Las guías existentes fueron evaluadas en términos de calidad y aplicabilidad; ninguna de ellas cumplió criterios de adaptación, por lo que se decidió desarrollar una guía de novo. El Grupo Cochrane realizó la búsqueda sistemática de la literatura. Las tablas de evidencia y recomendaciones fueron realizadas usando la metodología GRADE. Resultados: se desarrolló una guía de práctica clínica basada en la evidencia para el diagnóstico, clasificación y tratamiento farmacológico y no farmacológico de los pacientes con estreñimiento crónico funcional en Colombia. Conclusiones: se establecieron los criterios clínicos y signos de alarma, las pruebas diagnósticas y los esquemas terapéuticos que se recomiendan en la atención de los pacientes con estreñimiento crónico funcional en Colombia.

Objective: Design a clinical practice guideline to orient the diagnosis and establishing the classification and pharmacological and non-pharmacological treatment in adult patients with chronic functional constipation in Colombia. Materials and Methods: This guide was developed by a multidisciplinary team with the support of the Colombian Association of Gastroenterology, Cochrane STI Group and Clinical Research Institute of the Universidad Nacional de Colombia. Relevant clinical questions were developed and the search for national and international guidelines in databases was performed. Existing guidelines were evaluated for quality and applicability. None of the guidelines met the criteria for adaptation, so the group decided to develop a de novo guideline. Systematic literature searches were conducted by the Cochrane Group. The tables of evidence and recommendations were made based on the GRADE methodology. Results: A clinical practice based on evidence was developed for the diagnosis, classification and pharmacological and non-pharmacological treatment of patients with chronic functional constipation in Colombia. Conclusions: The clinical criteria and warning signs, diagnostic tests and therapeutic regimens that are recommended in the care of patients with chronic functional constipation were established in Colombia.

D-dimer is a significant prognostic factor in patients with suspected infection and sepsis.

PURPOSE: The aim of the study was to determine whether C-reactive protein (CRP), procalcitonin (PCT), and d-dimer (DD) are markers of mortality in patients admitted to the emergency department (ED) with suspected infection and sepsis. BASIC PROCEDURES: We conducted a prospective cohort in a university hospital in Medellín, Colombia. Patients were admitted between August 1, 2007, and January 30, 2009. Clinical and demographic data and Acute Physiology and Chronic Health Evaluation II and Sepsis Organ Failure Assessment scores as well as blood samples for CRP, PCT, and DD were collected within the first 24 hours of admission. Survival was determined on day 28 to establish its association with the proposed biomarkers using logistic regression and receiver operating characteristic curves. MAIN FINDINGS: We analyzed 684 patients. The median Acute Physiology and Chronic Health Evaluation II and Sepsis Organ Failure Assessment scores were 10 (interquartile range [IQR], 6-15) and 2 (IQR, 1-4), respectively. The median CRP was 9.6 mg/dL (IQR, 3.5-20.4 mg/dL); PCT, 0.36 ng/mL (IQR, 0.1-3.7 ng/mL); and DD, 1612 ng/mL (IQR, 986-2801 ng/mL). The median DD in survivors was 1475 ng/mL (IQR, 955-2627 ng/mL) vs 2489 ng/mL (IQR, 1698-4573 ng/mL) in nonsurvivors (P=.0001). The discriminatory ability showed area under the curve-receiver operating characteristic for DD, 0.68; CRP, 0.55; and PCT, 0.59. After multivariate analysis, the only biomarker with a linear relation with mortality was DD, with an odds ratio of 2.07 (95% confidence interval, 0.93-4.62) for values more than 1180 and less than 2409 ng/mL and an odds ratio of 3.03 (95% confidence interval, 1.38-6.62) for values more than 2409 ng/mL. PRINCIPAL CONCLUSIONS: Our results suggest that high levels of DD are associated with 28-day mortality in patients with infection or sepsis identified in the emergency department.

Evaluación del manejo interdisciplinario de una serie de 53 pacientes con hepatolitiasis / Evaluation of interdisciplinary care of a series of 53 patients with hepatholithiasis

Objetivos: Evaluar, en una serie de enfermos con hepatolitiasis, el resultado del manejo interdisciplinario. Pacientes y métodos: Durante 8 años se valoraron, en un estudio retrospectivo, 53 pacientes con diagnóstico de hepatolitiasis. Resultados: Se estudiaron 23 hombres (43%) y 30 mujeres con una edad promedio de 50 ± 15 años (25 a 83 años). Predominó el dolor (94%), seguido de ictericia (68%) y fiebre (57%). Según la clasificación de Tsunoda, 6 pacientes eran Tsunoda I, 12 Tsunoda II, 4 Tsunoda III y 5 Tsunoda IV. El compromiso más frecuente fue del lóbulo izquierdo (36%) o bilateral (34%). La colangiografía endoscópica tuvo éxito en el 64% y solo se manejaron 4 pacientes por la vía transparietohepática (2 éxitos). Se operaron 35 pacientes (66%) y lo más frecuente fue la hepatectomía izquierda en 40% (7 con asa subcutánea) seguida por hepaticoyeyunostomía con asa subcutánea (26%). Se realizaron cuatro trasplantes ortotópicos de hígado que evolucionan asintomáticos en pacientes con complicaciones por cirrosis. Las complicaciones postoperatorias tempranas fueron del 40%, la más frecuente la infección del sitio operatorio (14%) y cálculos residuales (9%). La complicación tardía más usual fue la litiasis residual (23%). El 80% de los pacientes operados están asintomáticos comparados con el 72% de los no operados. No hubo mortalidad quirúrgica. Conclusiones: La hepatolitiasis es una entidad con manejos no bien estandarizados, entre ellos, la opción quirúrgica cursa con buenos resultados, mejoría clínica y poca morbimortalidad; con el apoyo interdisciplinario dado la radiología intervencionista y la endoscopia biliar.

Objectives: Evaluate the results of interdisciplinary care in a series of patients with hepatolithiasis. Patients and Methods: A retrospective study of 53 patients with hepatolithiasis who were evaluated over an eight year period. Results: 23 men (43%) and 30 women were studied. The average age was 50 ± 15 years (range: 25-83 years). Pain was the predominant symptom (94%), followed by jaundice (68%) and fever (57%). According to the Tsunoda classification, 6 patients were Tsunoda I, 12 were Tsunoda II, 4 were Tsunoda III, and 5 were Tsunoda IV. Left lobe hepatolithiasis was most frequent (36%), followed by bilateral hepatolithiasis (34%). Endoscopic cholangiography was successful in 64% of patients. Only 4 patients were treated by percutaneous cholangiography, with 2 successes. 35 patients (66%) were operated on. The most frequent surgery was left hepatectomy with subcutaneous loop in 7 patients (40%), followed by hepatojejunostomy with subcutaneous loop (26%). Four orthotopic liver transplantations with good evolution were performed in patients with cirrhotic complications. 40% had early complications. Most frequent were infection of the operative site (14%) and residual stones (9%). The most frequent delayed complication was residual lithiasis (23%). 80% of the patients who underwent surgery were asymptomatic compared with 72% of those who did not undergo surgery. There were no mortalities resulting from surgery. Conclusions: Hepatolithiasis is a disease which does not have a well standardized treatment. Surgery is an alternative with good results, clinical improvement and low morbidity and mortality rates when there is interdisciplinary including interventionist radiology and biliary endoscopy.

Stent metálico versus plástico en la obstrucción biliar maligna distal / Metal stent versus plastic stent for malignant distal biliary stricture

Antecedentes. En nuestro medio no se conocen estudios que comparen los stents metálicos (SM) y los stents plásticos (SP) en el manejo de la obstrucción biliar maligna distal. Pacientes y métodos. Estudio retrospectivo con 80 pacientes tratados en el Hospital Pablo Tobón Uribe y la Clínica el Rosario entre enero de 2002 y junio de 2008. Cuarenta pacientes se manejaron con SP y otros 40 con SM.Resultados. Se evaluaron 48 (60%) hombres y 32 mujeres (promedio 66±6 años) con obstrucción maligna biliar distal inoperable. El éxito clínico fue igual para ambos procedimientos (92%) La estancia hospitalaria fue significativamente menor para los pacientes con SM que para aquellos con SP (IC 95% 1,6-7,2, p<0,01). La obstrucción del stent biliar recurrió en 19 pacientes de los 40 SP (47,51%) y 13 de 40 (32,5%) con SM (p=0,2) La media de la permeabilidad fue más prolongada en los pacientes con SM que en los plásticos (IC 95% 41,1-90,8, p<0,01) Las complicaciones tempranas se sucedieron en el 5% de los SM y 12,5% de los SP (p=0,4); las complicaciones tardías fueron del 42,5% en los SP y del 30% en los SM (p=0,3) La sobrevida fue de 159,4±9,4 días en los pacientes con SP y de 189,5±7,6 días para los pacientes con SM (p=0,07).Conclusiones. Los stents metálicos y plásticos son efectivos para el tratamiento de la obstrucción maligna distal inoperable, pero los stents metálicos cursan con una mayor permeabilidad, menor estancia hospitalaria y menor número de reintervenciones por complicaciones, pero la sobrevida para ambos es igual.

Background: It is not known in our studies that compare metallic stents (SM) and plastic stents (SP) in the management of distal malignant biliary obstruction. Patients and Methods: Retrospective trial of 80 patients treated in Hospital Pablo Tobón Uribe and Clínica el Rosario between January 2002 and June 2008. Forty patients received a PS and 40 patients were treated with MS. Results. In this study, 48 men (60%) and 32 women (median 66±6 years) with inoperable malignant distal common bile duct strictures were evaluated. Clinical success was equal for two groups (92%). Hospital stay was significantly smaller for patients with MS than the patients with PS (CI 95% 1.6-7.2, p<0.01) Recurrent biliary obstruction was noted in 19 of 40 (47.5%) patients of PS and 27 of 108 (25%) patients of MS. The median first stent patency was longer in the metal group than in the plastic stent group (CI 95% 41.1-90.8, p<0.01). Early complications occurred in 5% of MS and 12.5% of patients with PS (p=0.4), later complications were seen in 42.5% of PS and 30% of MS (p=0.3) Median survival time after stent insertion was 159.4±9.4 days for PS and 189.5±7.6 days for MS (p=0.07).Conclusions. Plastic and metal stents are effective in the treatment of inoperable distal malignant obstruction, but compared with plastic stent, metal stents had better permeability, lower hospital stay, lower procedures for complications and equal survival.

Canulación biliar con guía en el conducto pancreático / Biliary cannulation with a guidewire in pancreatic duct

Antecedentes y objetivos. La piedra angular en la colangiografía radica en una canulación biliar atraumática y rápida, lo que redunda en el éxito del procedimiento. En esta serie de 10 pacientes se describe una técnica simple que ayuda a canular la vía biliar difícil. Métodos. En los casos en que repetidamente se canula el conducto pancreático y no selectivamente la vía biliar, se sugiere dejar la punta de la guía en la mitad del conducto Wirsung y retirar la cánula o esfinterótomo. La cánula o el esfinterótomo se reintroduce por el canal de trabajo al lado de la guía en el conducto pancreático y desde allí se avanza encontrando un mejor direccionamiento, estabilidad y firmeza de la papila. Resultados. Se usó esta técnica en 10 casos (6 hospitalizados y 4 ambulatorios) y fue exitosa en todos los pacientes, obviando la necesidad del acceso a la vía biliar por la técnica del precorte. Ninguna complicación fue documentada. Conclusiones. El uso de esta técnica puede ayudar a reducir el número de esfinterotomías por precorte, con su riesgo incrementado e inherente de pancreatitis, sangrado y perforación. La técnica propuesta puede ayudarnos en cualquier canulación difícil de la vía biliar.

Background and objectives. The angular stone in endoscopic colangiography is an atraumatic and fast biliary cannulation, which results in the success of the procedure. In this series of 10 patients an easy technique is described that helps to cannulate a difficult biliary conduit. Methods. In cases of repeatedly cannulation of pancreatic duct and not selectively the biliary tract; it is suggested to leave the guide wire in the middle of the Wirsung duct and to retire the cannula or sphincterotome. The cannula or sphincterotome is reintroduced by the work channel next to the guide wire in the pancreatic conduit. With the guide in the pancreatic duct the cannula advances with better direction, stability and firmness of papilla. Results. This technique cases was used in 10 patients (6 hospitalized and 4 ambulatory) and was successful in all the patients, avoiding the necessity of the access to the biliary route by the technique of the precut. No complication was documented.Conclusions. Use of this technique can help to reduce the number of sphincterotomies by precuts, with increased risks of pancreatitis, bleeding and perforation. The proposed technique can help us in any difficult cannulation of the biliary route.