An efficient strategy for evaluating new non-invasive screening tests for colorectal cancer: the guiding principles.

OBJECTIVE: New screening tests for colorectal cancer (CRC) are rapidly emerging. Conducting trials with mortality reduction as the end point supporting their adoption is challenging. We re-examined the principles underlying evaluation of new non-invasive tests in view of technological developments and identification of new biomarkers. DESIGN: A formal consensus approach involving a multidisciplinary expert panel revised eight previously established principles. RESULTS: Twelve newly stated principles emerged. Effectiveness of a new test can be evaluated by comparison with a proven comparator non-invasive test. The faecal immunochemical test is now considered the appropriate comparator, while colonoscopy remains the diagnostic standard. For a new test to be able to meet differing screening goals and regulatory requirements, flexibility to adjust its positivity threshold is desirable. A rigorous and efficient four-phased approach is proposed, commencing with small studies assessing the test's ability to discriminate between CRC and non-cancer states (phase I), followed by prospective estimation of accuracy across the continuum of neoplastic lesions in neoplasia-enriched populations (phase II). If these show promise, a provisional test positivity threshold is set before evaluation in typical screening populations. Phase III prospective studies determine single round intention-to-screen programme outcomes and confirm the test positivity threshold. Phase IV studies involve evaluation over repeated screening rounds with monitoring for missed lesions. Phases III and IV findings will provide the real-world data required to model test impact on CRC mortality and incidence. CONCLUSION: New non-invasive tests can be efficiently evaluated by a rigorous phased comparative approach, generating data from unbiased populations that inform predictions of their health impact.

Minimizing the Risks of Simethicone in Endoscope Reprocessing.

This statement was written under the auspices of the World Gastroenterology Organization's Guidelines Committee. The authors are members of the Review Team of the WGO Endoscope Disinfection Guideline and have experience in endoscopy, endoscope reprocessing, and microbiology, including biofilms. During the preparation of the WGO Update on Endoscope Disinfection Guidelines, concerns about simethicone on endoscope channel surfaces compromising cleaning and disinfection were raised. Publications on simethicone, including modes of delivery, effectiveness, and risks, have been reviewed. The paper was written as a companion to the new guidelines with a focus on minimizing the risks of simethicone in endoscope reprocessing.

Uniting the Global Gastroenterology Community to Meet the Challenge of Climate Change and Nonrecyclable Waste.

Climate change has been described as the greatest public health threat of the 21st century. It has significant implications for digestive health. A multinational team with representation from all continents, excluding Antarctica and covering 18 countries, has formulated a commentary which outlines both the implications for digestive health and ways in which this challenge can be faced.

Adult education. Gastroenterology training today.

Gastroenterology education has changed in recent years and the quality criteria are now the aim of it. Adult education is not intuited, it is to be learned. In our days post graduated education needs longer periods of training, because of the everyday development of new techniques and also because the e-learning /e-teaching has appeared in the arena.

Adult education: gastroenterology training today / Educación en el adulto: entrenamiento en gastroenterología

La educación en gastroenterología ha cambiado en los años recientes y el criterio de calidad es ahora la meta principal. La educación en el adulto no es intuitiva sino que tiene que ser aprendida. En nuestros días la educación del post graduado en gastroenterología necesita de periodos mayores de aprendizaje debido al desarrollo constante de nuevas técnicas y también porque el e-aprendizaje y la e-enseñanza han entrado al ruedo.

Gastroenterology education has changed in recent years and the quality criteria are now the aim of it. Adult education is not intuited, it is to be learned. In our days post graduated education needs longer periods of training, because of the everyday development of new techniques and also because the e-learning /e-teaching has appeared in the arena.

[Orange oily anal leakage: a new entity linked to dietary changes]. / Escurrimiento oleoso anaranjado o "keriorrea", ("orange oily anal leakage"): una nueva enfermedad ligada a cambios de hábito alimentario.

INTRODUCTION: Information is accumulating on exceptional cases of oily orange anal leakage, probably caused by certain foods and their form of consumption. The leakage is usually inadvertent and is worrisome for patients. METHOD: Clinical data was gathered on a case series presenting with massive and inadvertent orange oily anal leakage, without sphincter sensation, causing the patients to feel alarmed. This condition usually occurs after eating fish, especially Japanese cuisine. RESULTS: Eleven patients were included (four women and seven men). The mean age was 47.3 years. Colonoscopy had previously been performed in four patients, with normal results. The symptoms, described as keriorrhea, were probably produced by accumulation of indigestible "wax esters", es Mero present in some oily fish, recently incorporated in raw fish dishes (sashimi) or as Japanese Mero sea bass. These oils, which cannot be absorbed or digested, accumulate in the rectum and may also filter spontaneously and induce toxin-related sphincter dysfunction. The same symptoms are sometimes produced after consumption of cooked versions of these species. The diagnosis is given by clinical data, prior ingestion of these types of fish and the self-limiting nature of the symptoms, without the need for further investigations. CONCLUSION: We describe a case series of a recently described entity associated with dietary changes. This entity is benign and self-limiting. Clinicians should be familiar with the symptoms to inform patients correctly and avoid unnecessary laboratory studies.

Gastroenterology training in Latin America.

Latin America is characterized by ethnic, geographical, cultural, and economic diversity; therefore, training in gastroenterology in the region must be considered in this context. The continent's medical education is characterized by a lack of standards and the volume of research continues to be relatively small. There is a multiplicity of events in general gastroenterology and in sub-disciplines, both at regional and local levels, which ensure that many colleagues have access to information. Medical education programs must be based on a clinical vision and be considered in close contact with the patients. The programs should be properly supervised, appropriately defined, and evaluated on a regular basis. The disparity between the patients' needs, the scarce resources available, and the pressures exerted by the health systems on doctors are frequent cited by those complaining of poor professionalism. Teaching development can play a critical role in ensuring the quality of teaching and learning in universities. Continuing professional development programs activities must be planned on the basis of the doctors' needs, with clearly defined objectives and using proper learning methodologies designed for adults. They must be evaluated and accredited by a competent body, so that they may become the basis of a professional regulatory system. The specialty has made progress in the last decades, offering doctors various possibilities for professional development. The world gastroenterology organization has contributed to the speciality through three distinctive, but closely inter-related, programs: Training Centers, Train-the-Trainers, and Global Guidelines, in which Latin America is deeply involved.

[Colorectal cancer screening at Clínica Alemana, Santiago de Chile]. / Plan de tamizaje de cáncer colorrectal ("Mes del Colon") en la Clínica Alemana de Santiago de Chile.

INTRODUCTION: Colorectal cancer (CRC) incidence is rapidly increasing. It has been demonstrated that it can be prevented and cured when the diagnosis is made in early stages. OBJECTIVE: For this reason it is necessary to apply a screening program in asymptomatic patients. METHOD: Since 2003, we conducted a CRC screening plan called "Mes del Colon" at Clínica Alemana Santiago. A press and local diffusion campaign was designed. Open to the community CRC talks were scheduled. An ad hoc database was designed. An informed consent was available. Patients older than 50 years and high risk patients were included. Total colonoscopy and a medical interview after the procedure were included in the plan with favorable economic conditions. RESULTS: Since 2003, 1158 patients were included The 1.8% of them were excluded because of incomplete data or because they did not meet the inclusion criteria. The 54% of patients were women. Mean age was 58.4 years old and mean body mass index 25.5 kg/m2. Polipoid lesions were seen in 45% of the patients. Six (1%) of them were adenocarcinomas, 291 (57%) adenomas (98% tubular adenomas), 189 (37%) hyperplastic polyps and 25 (5%) miscellaneous lesions. In this series, the necessary number to investigate for 1 adenoma was 3.9. CONCLUSIONS: CRC prevention campaigns are needed due to the continuous increase of the incidence in our country. The detection of precursor or early lesions that are longstanding before becoming advanced cancer allows its treatment avoiding progression.

[Endoscopic argon plasma coagulation in recurrent tracheoesophageal fistula. Clinical series and review of the literature]. / Tratamiento endoscópico con argón plasma en fístula traqueoesofágica recurrente. Serie clínica y revisión de la literatura médica.

INTRODUCTION: Recurrent tracheoesophageal fistula (RTEF) is a complication that occurs in up to 15% of patients after esophageal atresia repair. The clinical features include coughing, aspiration, recurrent pneumonia and failure to thrive. Surgical treatment is recommended. However, since 1980, the endoscopic route has been used as a therapeutic alternative. Distinct techniques have been employed with an overall success rate of 63%. PURPOSE: To evaluate a new endoscopic treatment for RTEF with argon plasma coagulation (APC). METHODS: Six patients with RTEF treated with endoscopic APC between 2003 and 2007 at a single institution (Clinica Alemana, Santiago, Chile) were included. We also performed a systematic literature search. Nineteen articles were selected, with a total of 77 patients treated through the endoscopic route. RESULTS: Treatment was successful in 66% of the patients with a follow-up of more than 12 months. On average, the patients required two applications of APC. This success rate was similar to that reported in published series. CONCLUSION: Endoscopic treatment with APC in RTEF seems to be useful and easily applied. Because of the complexity of surgical treatment, we recommend endoscopic treatment as the first approach in patients with RTEF.

[Inverted colonic diverticula: an uncommon endoscopic finding]. / Divertículo colónico invertido: un hallazgo endoscópico infrecuente.

BACKGROUND: The appearance of inverted colonic diverticula (ICD) is similar to that of elevated polypoid lesions. The aim of this study was to describe the endoscopic characteristics of ICD with a view to avoiding misdiagnosis, and to report the frequency of these lesions. MATERIAL AND METHOD: Using an endoscopic database, we retrospectively analyzed all patients who underwent colonoscopy at our institution between July 2001 and July 2004. Patients diagnosed with ICD were identified and both patient and ICD characteristics were recorded, including location, endoscopic characteristics, and the presence of synchronous colon polyps. RESULTS: Among the 4508 colonoscopies performed in the selected period, 33 patients (0.7%) were diagnosed with ICD. The mean age was 62.3 years, with a male-to-female ratio of 1:1.2. Most ICD (89%) were in an area of multiple colonic diverticula and 75% were located in the sigmoid colon. One patient had active bleeding directly from the inverted diverticulum and was treated with injection therapy. The endoscopic characteristics of ICDs were described. There were no complications in this series. CONCLUSIONS: ICD is a rare endoscopic finding that can be complicated by local bleeding. Misdiagnosis can be dangerous and biopsy or endoscopic resection could lead to serious complications. The endoscopic criteria described should be considered to avoid the complications associated with biopsy or resection.

Utilidad de los predictores clásicos de severidad en pancreatitis aguda / Usefulness of the classic predictors of severity in acute pancreatitis

Objetivo. Evaluar la utilidad de las escalas tradicionales de Ranson, Glasgow, Apache II y Balthazar en la predicción de la severidad de la pancreatitis aguda. Métodos. De forma prospectiva en el servicio de Gastroenterología del HCAM analizamos una serie de casos, entre julio del 2005 y julio del 2006. Se incluyeron 135 de 138 pacientes con pancreatitis aguda, que cumplieron con los criterios de inclusión. Se obtuvo datos clínicos, estudios de laboratorio e imagen para establecer los valores de las escalas de Ranson, Glasgow, Apache 11 y Balthazar. Calculamos sensibilidad, especificidad, valor predictivo positivo (YPP), valor predictivo negativo (VPN) y Likelihood ratio (LR) de cada escala. Resultados. De los 135 pacientes, 101 (74.8%) presentaron PA leve y 34 (25.2%) PA grave. El valor promedio (OS) de las escalas evaluadas en los pacientes con PA leve versus grave fue: Ranson 2,64 (1,41) vs 4,6 (1 ,6); Glasgow 1,81 (1,17) vs 3,32 (1,42); Apache TI 6,84 (3,63) vs 11,82 (5,05); ISTC 1,63 (1,14) vs 7,47 (1,97). La sensibilidad, especificidad, YPP y VPN para cada escala fue: Ranson 76,5%, 72,2%, 48,1%, y 90,1%; Glasgow 70,6%, 72,3%, 46,2% y 87, 9%; Apache 11 82,3%, 57,4%, 39,4% y 90.6%; ISTC 79,4%, 100%, 100% y 93.5% respectivamente, Conclusión. Oe acuerdo a nuestros resultados en esta serie, el ISTC es la mejor escala para predecir la severidad de la PA. Tiene el inconveniente de la temporalidad, ya que se requiere esperar más de 48 horas, para la valoración real.

Imágenes de banda estrecha o Narrow band imaging (NBI): una nueva era en endoscopía digestiva / Narrow band imaging (NBI): the new era digestive endoscopy

El NBI o imagen de banda estrecha es un novedoso sistema de visualización endoscópica que posibilita una valoración en detalle de la superficie mucosa y su patrón vascular. Esto permite un avance cualitativo en el diagnóstico de las lesiones del tubo digestivo, así como una sustancial mejora en el seguimiento de enfermedades tales como esófago de Barrett, cáncer y pólipos colorrectales y enfermedad inflamatoria intestinal, entre otras.El lograr un manejo adecuado de los pacientes con menor riesgo y mayor seguridad parece ser un objetivo cercano mediante la aplicación de esta nueva técnica, la cual se encuentradisponible para su aplicación clínica mediante la simple presión de un botón del endoscopio.

NBI is a brand new technique for endoscopic visualization that allows a detailed assessment of the mucous surface and its vascular pattern. This involves a qualitative progress in the diagnosis of lesions in the digestive tube,as well as an improvement in follow-up of diseases such as Barrett's esophagus, cancer, colorectal polyps and intestinalinflammatory disease, among others. Managing to properly treat patients, lowering risks and increasing safety, may be a reachable goal by applying this new technique, which is available for clinical use by simply pressing a key on the endoscopy.

A NBI ou imagem de banda estreita é um novo sistema de visualização endoscópica que possibilita a realização de uma avaliação detalhada da superfície mucosa e de seu padrão vascular. Isto permite um avanço qualitativo no diagnóstico das lesões do tubo digestivo, bem como uma melhoria considerável no acompanhamento de doenças como o esôfago de Barrett, câncer e pólipos colorretais e da doença inflamatória intestinal, entre outras.Conseguir um manejo adequado dos pacientes com menos risco e maior segurança parece ser um objetivo próximo a ser alcançado pela aplicação desta nova técnica, que está disponível para utilização clínica pela simplespressão sobre um botão do endoscópio.