Active surveillance as the initial treatment of papillary thyroid microcarcinoma: a 10-years multicentric prospective study

Abstract

BACKGROUND: Papillary thyroid microcarcinoma has extensively been proved to have an excellent prognosis. The results of autopsy series and mass-screening studies suggest that a significant percentage of population have this disease, but its behaviour is mostly indolent. However, when an incidental microcarcinoma is diagnosed, aggressive surgical treatment is the current recommendation. Two hospitals in Japan started treating these patients with active surveillance, following them with periodic control visits and only recommending surgery after demonstrated disease progression. Even though the results with this conservative strategy are promising, there is no study that specifically compares both managements. OBJECTIVE: The objective of this study is to determine whether active surveillance is an appropriate alternative to initial surgery in the management of patients with papillary microcarcinoma of the thyroid with good prognostic factors. METHODS: This will be a longitudinal, prospective, non-randomized, controlled trial. It will be set in the CeCAT consortium hospitals, with the Hospital Universitari Josep Trueta as the reference center. The participants will be 191 patients diagnosed with papillary thyroid microcarcinoma in the CeCAT centers, using a consecutive non-probabilistic sequential sampling. The patients will be separated in 2 groups, according to the treatment decision, in “active surveillance group” and “initial surgery group”, and then followed with periodic control visits during 10 years. Progression of the disease will be the dependent variable, and will be measured using ultrasonographic criteria. Progression will be defined either by the appearance of cervical lymph nodes, the enlargement of the primary microcarcinoma or the reappearance of lesions in the thyroid bed. Percentages, means +/- standard deviation, χ² test and logistic regression will be performed to analyze and describe the results of the study