Microcarcinoma papilar de tiroides: vigilancia activa. Revisión de la bibliografía / Papillary thyroid microcarcinoma: active surveillance. Literature review

El cáncer de tiroides ha aumentado en incidencia, sin embargo, la mortalidad se mantiene estable. Muchas de estas lesiones son a expensas de un microcarcinoma papilar de tiroides definido por la OMS como aquel carcinoma papilar de tiroides que en su diámetro máximo no sobrepasa los 10 mm. El avance de la imagenología sobre todo la ecografía de alta resolución y el hallazgo en pieza de anatomía patológica por lesiones benignas son las principales causas del aumento en el diagnóstico de esta entidad. La vigilancia activa surge entonces como alternativa de manejo para pacientes portadores de microcarcinoma papilar con bajo riesgo de progresión, obteniendo resultados oncológicos comparables. Independiente de su tratamiento el pronóstico de estos pacientes es excelente con sobrevida cercana al 100% en 10 años. A pesar de lo dicho la morbilidad de las distintas opciones terapéuticas es muy distinta. Será fundamental buscar elementos clínicos y paraclínicos que permitan tomar una decisión práctica, con el fin de determinar qué pacientes con microcarcinomas papilares que podrán entrar en un protocolo de vigilancia activa. Esta revisión pretende examinar la bibliografía publicada al respecto como alternativa de manejo, y su eventual aplicación en Uruguay.

Thyroid cancer has increased in incidence; however, mortality remains stable. Many of these lesions are at the expense of papillary thyroid microcarcinoma defined by the WHO as papillary thyroid carcinoma that in its maximum diameter does not exceed 10 mm. The advance of imaging, especially high-resolution ultrasound and the finding of benign lesions in pathological anatomy specimens are the main causes of the increase in the diagnosis of this entity. Active surveillance arises then as a management alternative for patients with papillary microcarcinoma with low risk of progression, obtaining comparable oncologic results. Regardless of their treatment, the prognosis of these patients is excellent with a survival rate close to 100% in 10 years. In spite of what has been said, the morbidity of the different therapeutic options is very different. It will be essential to look for clinical and paraclinical elements that will allow making a practical decision, in order to determine which patients with papillary microcarcinomas will be able to enter an active surveillance protocol. This review aims to examine the literature published on this subject as a management alternative, and its eventual application in Uruguay.

Rendimiento del sistema Bethesda en el diagnóstico citopatológico del nódulo tiroideo en un centro universitario (Hospital de Clínicas) de Uruguay, diez años de experiencia / Performance of the Bethesda SYSTEM in the cytopathological diagnosis of the thyroid nodule in a university center (Hospital de Clínicas) in Uruguay, ten years of experience / Desempenho do sistema Bethesda no diagnóstico citopatológico de nódulos tireoidianos em um centro universitário (Hospital de Clínicas) no Uruguai, dez anos de experiencia

Resumen: Introducción: el estudio citológico por punción ecoguiada se caracteriza por ser rápido, confiable, mínimamente invasivo y rentable. Permite reducir procedimientos quirúrgicos innecesarios y clasifica apropiadamente a los pacientes con nódulos sospechosos o malignos para una intervención quirúrgica oportuna. Objetivo: el objetivo del presente estudio es evaluar la correlación citológica-anatomopatológica del sistema Bethesda en un centro universitario (Hospital de Clínicas) de Uruguay. Metodología: se realizó un estudio de tipo observacional, retrospectivo, descriptivo, basado el análisis de historias clínicas de pacientes sometidos a cirugía tiroidea en el Hospital de Clínicas, en el período comprendido entre enero de 2008 y diciembre de 2018. Resultados: del total inicial de 119 pacientes, 93 cumplieron los criterios de inclusión. El rango de edad de la muestra fue entre 15 y 79 años. Del total de puncionados 49,5% (46) fueron informados como benignos y 50,5% (47) como malignos. Se calculó en forma global una sensibilidad de 96% (0,96) con IC 1,0-0,90, especificidad de 98% (0,97) con IC 1,0-0,93, un VPP de 98% y VPN de 96%. La sensibilidad diagnóstica para la categoría IV, V y VI fue de 96%, con una especificidad de 100, 94 y 100% respectivamente. Conclusiones: el sistema Bethesda aplicado a las PAAF de nódulos tiroideos potencia la certeza diagnóstica y asiste en la decisión terapéutica. En nuestra institución contamos con una buena correlación citopatológica, similar a otros trabajos reportados en la literatura, lo que permite predecir adecuadamente el riesgo de malignidad y facilitar la toma de decisiones.

Summary: Introduction: the ultrasound-guided fine needle aspiration biopsy (FNAB) study is characterized by being fast, reliable, minimally invasive, and cost-effective. It reduces unnecessary surgical procedures and appropriately classifies patients with suspicious or malignant nodules for timely surgical intervention. Objective: the objective of this study is to evaluate the cytological-pathological correlation of the Bethesda System in a university center (Hospital de Clínicas) in Uruguay. Methodology: an observational, retrospective, descriptive study was carried out, based on the analysis of medical records of patients undergoing thyroid surgery at the Hospital de Clínicas, in the period between January 2008 and December 2018. Results: of the initial total of 119 patients, 93 met the inclusion criteria. The age range of the sample was between 15 and 79 years. Of the total of punctured, 49.5% (46) were reported as benign and 50.5% (47) as malignant. A sensitivity of 96% (0.96) with CI 1.0-0.90, specificity of 98% (0.97) with CI 1.0-0.93, a PPV of 98% and NPV of 96%. The diagnostic sensitivity for categories IV, V and VI was 96% with a specificity of 100, 94 and 100% respectively. Conclusions: the Bethesda system applied to FNA of thyroid nodules enhances diagnostic certainty and assists in the therapeutic decision. In our institution we have a good cytopathological correlation, similar to other works reported in the literature. This makes it possible to adequately predict the risk of malignancy and facilitate decision-making.

Resumo: Introdução: o estudo citológico por punção guiada por ultrassom caracteriza-se por ser rápido, confiável, minimamente invasivo e de baixo custo. Permite reduzir procedimentos cirúrgicos desnecessários e classificar adequadamente pacientes com nódulos suspeitos ou malignos para intervenção cirúrgica oportuna. Objetivo: avaliar a correlação citológico-patológica do Sistema Bethesda em um centro universitário (Hospital de Clínicas) no Uruguai. Metodologia: foi realizado um estudo observacional, retrospectivo, descritivo, baseado na análise de prontuários de pacientes submetidos à cirurgia de tireoide no Hospital de Clínicas, no período janeiro de 2008-dezembro de 2018. Resultados: do total inicial de 119 pacientes, 93 preencheram os critérios de inclusão. A faixa etária da amostra foi entre 15 e 79 anos. Do total de punções, 49,5% (46) foram relatadas como benignas e 50,5% (47) como malignas. No geral, uma sensibilidade de 96% (0,96) com IC 1,0-0,90, uma especificidade de 98% (0,97) com IC 1,0-0,93, um VPP de 98% e VPN de 96%. A sensibilidade diagnóstica para as categorias IV, V e VI foi de 96% com especificidade de 100, 94 e 100%, respectivamente. Conclusões: o sistema Bethesda aplicado à PAAF de nódulos tireoidianos aumenta a certeza diagnóstica e auxilia na decisão terapêutica. Em nossa instituição temos uma boa correlação citopatológica, semelhante a outros trabalhos relatados na literatura. Isso permite prever adequadamente o risco de malignidade e facilitar a tomada de decisão.

Metástasis cervical de cáncer papilar oculto de tiroides: reporte de casos / Cervical metastasis from occult papillary thyroid cancer: case report

El microcarcinoma papilar de tiroides es definido como un tumor de un cm o menos de diámetro mayor. La mayoría permanecen ocultos clínicamente, siendo un hallazgo en autopsias hasta en 36%. La presentación oculta ocurre hasta en un 10 a 26% de todas las neoplasias malignas de tiroides y se define como la presencia de ganglios metastásicos de carcinoma papilar de tiroides en ausencia de lesión primitiva tiroidea evidente durante la exploración clínica y ecográfica. El objetivo de este trabajo es el reporte de dos casos donde el diagnóstico de cáncer de tiroides se realizó a través de su presentación metastásica cervical, siendo el estudio anatomopatológico de la pieza de resección quirúrgica el que devela la presencia de un microcarcinoma papilar. Si bien el tratamiento del de estas lesiones es controversial, existen elementos que sellan la necesidad de resolución quirúrgica. En el debut metastásico ganglionar cervical, está indicada la tiroidectomía total con el vaciamiento ganglionar cervical radical modificado ipsilateral y central. El raidioyodo postquirúrgico será empleado en forma complementaria ante la persistencia, recurrencia o elementos de alto riesgo.

Papillary thyroid microcarcinoma is defined as a tumor one cm or less in diameter. Most remain clinically hidden, being an autopsy finding in up to 36%. Occult presentation occurs in up to 10% to 26% of all thyroid malignancies and is defined as the presence of metastatic nodes from papillary thyroid carcinoma in the absence of a primitive thyroid lesion evident on clinical and ultrasound examination. The objective of this work is the report of two cases where the diagnosis of thyroid cancer was made through its cervical metastatic presentation, being the pathological study of the surgical resection specimen that reveals the presence of a papillary microcarcinoma. Although the treatment of these lesions is controversial, there are elements that seal the need for surgical resolution. In cervical lymph node metastatic debut, total thyroidectomy with modified ipsilateral and central radical cervical lymph node dissection is indicated. Post-surgical radiation iodine will be used in a complementary way in the event of persistence, recurrence or high-risk elements.

Hiperparatiroidismo primario: experiencia en cirugía por mini abordaje unilateral / Primary hyperparathyroidism: experience in surgery by unilateral mini-approach

INTRODUCCIÓN: En el hiperparatiroidismo primario el origen del trastorno, como su nombre lo indica, está en la propia glándula paratiroides, la cual genera una secreción autónoma y excesiva. La cirugía de las glándulas paratiroides evolucionó en forma considerable en los últimos 30 a 40 años, pasamos de exploraciones cervicales exhaustivas, hasta una época en que gracias al desarrollo tecnológico y sobre todo medicina nuclear, podemos localizar en forma preoperatoria el tejido patológico; siendo esta a su vez la base fundamental en la realización de procedimientos más selectivos. OBJETIVO: mostrar la casuística de cirugía por mini abordaje de la glándula paratiroides en el hiperparatiroidismo primario en un centro mutual de Montevideo. MATERIAL Y MÉTODOS: Realizamos un estudio observacional descriptivo y retrospectivo. Se estudió una muestra de 18 pacientes con diagnóstico de hiperparatiroidismo primario y con sospecha de lesión única los cuales fueron intervenidos en un centro mutual de la ciudad de Montevideo entro julio de 2017 y enero de 2020. CONCLUSIÓN: La cirugía por mini abordaje de la glándula paratiroides puede ser aplicada en el hiperparatiroidismo primario en pacientes seleccionados con las ventajas de; tener un menor tiempo quirúrgico, ser ambulatoria (reintegro al hogar en pocas horas), indemnidad de la logia tiroidea contralateral, mejor resultado estético con similar tasa de éxito que la cirugía convencional.

BACKGROUND: In primary hyperparathyroidism, the origin of the disorder, as its name indicates, is in the parathyroid gland itself, which generates excessive and autonomous secretion. Parathyroid gland surgery has evolved dramatically in the last 30 to 40 years, from exhaustive cervical examinations, to nowadays when, thanks to technological development and especially nuclear medicine, we can locate pathological tissue preoperatively; this, in fact, is the fundamental basis for the performance of more selective procedures. OBJECTIVE: to show the casuistry of mini-approach surgery of the parathyroid gland in primary hyperparathyroidism in a mutual center in Montevideo. METHODS: We carried out a descriptive and retrospective observational study. We studied a sample of 18 patients diagnosed with primary hyperparathyroidism and a single suspicious lesion, who underwent surgery in a private center in the city of Montevideo from July 2017 to January 2020. CONCLUSION: Mini-approach surgery of the parathyroid gland can be applied in primary hyperparathyroidism in selected patients, with the advantages of a shorter surgical time, ambulatory (return home in a few hours), keeping the indemnity of the contralateral thyroid loggia, a better cosmetic result with a similar success rate than conventional surgery.

Técnica con indocianina verde (ICG) como predictor de la falla de sutura: inicio de la experiencia en nuestro medio / Technical indocyanine green (ICG) as a predictor of suture failure

Objetivo: Valorar en el intraoperatorio en tiempo real, el flujo sanguíneo de los cabos anastomóticos y la anastomosis. El objetivo final de este trabajo busca que este sea el inicio de un estudio prospectivo, con el fin de auditar las anastomosis colónicas de forma intraoperatoria buscando así disminuir el número de fallas de suturas. Material y método: Se realizó un estudio prospectivo, observacional y descriptivo, desarrollado en el Hospital de Clínicas en el período comprendido entre enero de 2014 y julio 2015. Se incluyeron en el mismo pacientes sometidos a resección de colon y reconstrucción primaria del tránsito intestinal de coordinación. El indocianina verde (ICG) se empleó como colorante vital fluorescente para la valoración in situ de la anastomosis colónica. La presencia de falla de sutura en el postoperatorio en relación con la perfusión anastomótica objetivada con ICG constituye un parámetro de importancia en nuestro estudio. Resultados: En lo referente a la perfusión de la anastomosis, destacamos que en el primer caso la misma fue sensiblemente inferior en el cabo colónico, en tanto que en los 2 casos restantes la vascularización de los cabos fue óptima. Conclusiones: La técnica con ICG constituye una herramienta apropiada para poder auditar la calidad de las anastomosis intestinales realizadas de coordinación. Se trata de una técnica segura, aplicable en nuestro medio. Siendo un predictor de falla de sutura, permite un descenso de la morbimortalidad postoperatoria por esta causa.

Aim: Rate intraoperatively in real time, blood flow and ends anastomotic and anastomosis. The ultimate goal of this work seeks to make this the beginning of a prospective study in order to audit the colonic anastomosis intraoperatively and seeking to reduce the number of sutures failure. Material and method: A prospective, observational and descriptive study, to be held in the Clinics Hospital in the period between January 2014 and July 2015. They were included in the same patients undergoing resection of colon and intestinal transit reconstruction on primary coordination. Indocyanine green (ICG) was used as a fluorescent vital dye for in situ evaluation of colonic anastomosis. The presence of failure postoperative suture relative to the anastomotic objectified perfusion with ICG, is an important parameter in our study.Results:Regarding the perfusion of the anastomosis, in the first case it was significantly lower than in the colonic out. While in the remaining two cases the vascularization of the ends was optimal. Conclusions: The technique with indocyanine green is an appropriate tool to audit the quality of intestinal anastomoses performed coordination.

Bioequivalence of two film-coated tablets of imatinib mesylate 400 mg: a randomized, open-label, single-dose, fasting, two-period, two-sequence crossover comparison in healthy male South American volunteers.

BACKGROUND: Imatinib is a tyrosine kinase inhibitor that has been established as a highly effective therapy for chronic myelogenous leukemia and gastrointestinal stromal tumors. A new generic, once-daily 400-mg tablet of imatinib has been developed by a pharmaceutical company in Argentina, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing. OBJECTIVE: The aim of this study was to assess the bioequivalence of a new generic film-coated test tablet formulation versus a film-coated reference tablet formulation of imatinib 400 mg. The local manufacturer seeks to validate the in vitro performance of this new formulation with a bioequivalence study. METHODS: A randomized, open-label, single-dose, fasting, 2-period, 2-sequence crossover design with a 2-week washout period was used in this study. The study population consisted of healthy male South American (Uruguayan) volunteers, who were assigned in a 1:1 ratio to a randomized sequence (test-reference or reference-test). In each period, the test or reference formulation was administered after an overnight fast. During the 72-hour follow-up period, participants were monitored for vital signs and symptoms. Blood samples were collected at 15 time points, including baseline, until 72 hours. Physical examination and laboratory tests (blood, urine) were repeated 1 week after study completion. A noncompartmental model was used to determine the pharmacokinetic parameters of imatinib. The 90% CIs of the test/reference ratios for AUC(0-infinity) and C(max) were determined; the test and reference formulations were considered bioequivalent if the 90% CIs were between 0.80 and 1.25. Adverse events were assessed by a nurse who administered a questionnaire while the healthy volunteers were admitted in the unit. RESULTS: The bioequivalence study was conducted in 30 Uruguayan male volunteers. Demographic characteristics (mean [SD]) included age, 27.8 (6.5) years; weight, 71.2 (9.8) kg; height, 1.71 (0.09) m; and body mass index, 24.3 (3.0) kg/m2. The mean (SD) of AUC(0-infinity) was 38,179 (15,504) ng/mL x h(-1) for the test formulation and 40,554 (17,027) ng/mL x h(-1) for the reference formulation. The mean of Cmax for the test formulation was 2472 (933) ng/mL, and the mean Tmax was 3.28 (0.93) hours. The mean of Cmax for the reference formulation was 2566 (963) ng/mL, and the mean T(max) was 3.63 (1.20) hours. The point estimates (90% CIs) for the test/reference ratios of the log-transformed AUC- and C(max) mean values were 0.95 (0.87-1.03) and 0.97 (0.89-1.05), respectively, which met the regulatory criteria for bioequivalence. Thirty-four mild to moderate adverse events were reported (13 with the test formulation and 21 with the reference formulation), and no serious or unexpected adverse events were observed during the study. The adverse events included 16 cases of headache, 13 cases of nausea, 4 cases of vomiting, and 1 episode of diarrhea. CONCLUSIONS: The results of this study suggest that the test formulation of imatinib met the regulatory criteria for bioequivalence to the reference formulation in these healthy fasting male volunteers. Both formulations were generally well tolerated and appeared to have a similar adverse-event profile.