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.

[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.

[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.

[Barrett's esophagus. Update of the endoscopic treatment]. / Esófago de Barrett. Actualización del tratamiento endoscópico.

Actual Barrett's esophagus management includes symptomatic approach for GERD in order to prevent erosive injury and endoscopic & histologycal surveillance to detect dysplasia and early cancer. In high-grade dysplasia and superficial carcinoma, less aggressive procedures has been attempted to avoid extended surgery, such as Argon Plasma Coagulator, Multipolar Coagulation, Heater Probe, Photodynamic Therapy, and recently radiofrequency local treatment, associated or not to antireflux surgery. Ultrasonic therapy and Cryotherapy are new approaches, which are under clinical investigation. Barrett's epithelium resection utilizing endoscopical mucosal resection is a new promising procedure, which comes to the arena, allowing besides the compromised epithelium removal, its complete pathological evaluation and probably a curative intent. The actual revision intents to discuss the results of the different alternatives at the platform of treatment in dysplastic Barrett's or early carcinoma growing in the Barrett's epithelium.

[Endoscopic pancreatic sphincterotomy: when and how]. / Esfinterotomía pancreática: cuándo y cómo?

Endoscopic pancreatic sphincterotomy (EPS) has fallen into disuse for some time because of the risk of severe complications. More recently, EPS has been advocated as an effective treatment modality for several pancreatic disorders, including severe chronic pancreatitis, pancreatic pseudocyst, ampulloma, pancreas divisum, and pancreatic sphincter dysfunction. Favorable outcomes in patients undergoing EPS to facilitate further interventions, in whom long-term follow-up was available, was 70%; complications occurred in 14% and reintervention was required in 23%. The results were as good as those of surgery after long-term follow-up. Patients who underwent some form of pancreatic drainage after sphincterotomy had fewer complications (p = 0.03). Approximately 75% of patients with pancreas divisum who presented with idiopathic acute recurrent pancreatitis improved after endoscopic therapy, but only 25% of patients experienced pain reduction of at least 50%. The National Institutes of Health Consensus recommends EPS in patients with type I sphincter of Oddi dysfunction (SOD). In patients with type II SOD, prior manometry should be performed. In our series of 17 patients, we obtained results similar to those of other studies, although the number of patients was small. EPS appears to be a safe and effective technique, but further, well-designed, multicenter, prospective and long-term studies are required to evaluate these results and settle current controversies.

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.