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Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial. The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years. In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended. When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines. Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately. And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study.

Resumen Introduccion El objetivo de este estudio es llevar a cabo la evaluacion de la tecnica de deteccion del ganglio centinela (GC) con tincion de azul de metileno «ex vivo» en el cancer de colon, asi como calcular la supraestadificacion y su correlacion con la evolucion de la enfermedad. Metodos Entre 2008 y 2011, 101 pacientes fueron operados de cancer de colon con la deteccion del GC, estudiandose las micrometastasis. El seguimiento de los pacientes N0 fue mayor a un ano en busqueda de recidivas y si tenian relacion con la aparicion de dichas micrometastasis. Resultados El indice de deteccion del GC fue de 92 casos (91%). Fue positivo para micrometastasis en 9 casos, con una supraestadificacion del 14%. La incidencia de falsos negativos fue de 9 pacientes (10%). El seguimiento medio de los 74 pacientes N0 fue de 38 meses. Se observo recurrencia en 4 pacientes (7%) del grupo de pacientes con GC− (65 pacientes) y en 2 pacientes (22%) en el grupo con GC+ (9 pacientes, sin diferencias estadisticas significativas. Tampoco se observaron diferencias en terminos de supervivencia entre los 2 grupos. Conclusiones El estudio del GC es una practica reproducible sin aumento significativo del tiempo y de costes. Puede llegar a supraestadificar el 14% de pacientes que habian sido clasificados como N0 con tecnica convencional. En el seguimiento de los pacientes N0 con GC+ parece haber una tendencia a un porcentaje mayor de recidivas, lo que podria llevar a cambios en las pautas de tratamiento adyuvante, aunque debemos tomarlo con cautela ya que la muestra es escasa.

Introduction: The aim of this study is to evaluate the sentinel lymph node mapping (SLNM) with methylene blue staining "ex vivo" in colon cancer, as well as calculate the upstaging obtained by the determination of micrometastases and its correlation with the evolution of the disease. Methods: Between 2008 and 2011, 101 patients with colon cancer undergoing resection were studied prospectively with SLNM and detection of micrometastases. The correlation of SLN micrometastases with the disease evolution was evaluated in patients with a follow-up of more than one year. Results: The SLNM rate was 92 cases (91%). Only SLN was positive for micrometastases in 9 cases, with a 14% upstaging. The incidence of false negatives was 9 patients (10%). Mean follow of N0 patients (n = 74) was 38 months. The SLN-(negative) group (65 patients) had a recurrence rate of 4 patients (7%), whereas this rate was 2 patients (22%) in the group of SLN + (positive) (9 patients), but without significant differences. No differences in survival were observed. Conclusions: SLNM is a reproducible technique without significant increase in time and costs. Upstaging was obtained in 14% of patients staged as N0 by conventional technique. At follow-up of N0 patients with SLN + there seems to be a higher rate of recurrence, which could change the guidelines of adjuvant treatment, but we must interpret the results it with caution because the sample is small. (C) 2013 AEC. Published by Elsevier Espana, S.L.U. All rights reserved.