Protocol for a Korean Multicenter Prospective Cohort Study of Active Surveillance or Surgery (KoMPASS) in Papillary Thyroid Microcarcinoma

다국어 초록 (Multilingual Abstract)

Background: A Korean Multicenter Prospective cohort study of Active Surveillance or Surgery (KoMPASS) for papillary thyroidmicrocarcinomas (PTMCs) has been initiated. The aim is to compare clinical outcomes between active surveillance (AS) and an immediate lobectomy for low-risk PTMCs. We here outline the detailed protocol for this study.
Methods: Adult patients with a cytopathologically confirmed PTMC sized 6.0 to 10.0 mm by ultrasound (US) will be included. Patients will be excluded if they have a suspicious extra-thyroidal extension or metastasis of a PTMC or multiple thyroid nodules orother thyroid diseases which require a total thyroidectomy. Printed material describing the prognosis of PTMCs, and the pros andcons of each management option, will be provided to eligible patients to select their preferred intervention. For the AS group, thyroidUS, thyroid function, and quality of life (QoL) parameters will be monitored every 6 months during the first year, and then annuallythereafter. Disease progression will be defined as a ≥3 mm increase in maximal diameter of a PTMC, or the development of newthyroid cancers or metastases. If progression is detected, patients should undergo appropriate surgery. For the lobectomy group, a lobectomy with prophylactic central neck dissection will be done within 6 months. After initial surgery, thyroid US, thyroid function, serum thyroglobulin (Tg), anti-Tg antibody, and QoL parameters will be monitored every 6 months during the first year and annuallythereafter. Disease progression will be defined in these cases as the development of new thyroid cancers or metastases.
Conclusion: KoMPASS findings will help to confirm the role of AS, and develop individualized management strategies, for lowrisk PTMCs

참고문헌 (Reference)

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