Jeon Min Ji, Kang Yea Eun, Moon Jae Hoon, Lim Dong Jun, Lee Chang Yoon, Lee Yong Sang, Kim Sun Wook, Kim Min-Hee, Kim Bo Hyun, Kang Ho-Cheol, Shong Minho, Cho Sun Wook, Kim Won Bae
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea.
Endocrinol Metab (Seoul). 2021 Apr;36(2):359-364. doi: 10.3803/EnM.2020.890. Epub 2021 Mar 23.
A Korean Multicenter Prospective cohort study of Active Surveillance or Surgery (KoMPASS) for papillary thyroid microcarcinomas (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.
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 or other thyroid diseases which require a total thyroidectomy. Printed material describing the prognosis of PTMCs, and the pros and cons of each management option, will be provided to eligible patients to select their preferred intervention. For the AS group, thyroid US, thyroid function, and quality of life (QoL) parameters will be monitored every 6 months during the first year, and then annually thereafter. Disease progression will be defined as a ≥3 mm increase in maximal diameter of a PTMC, or the development of new thyroid 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 annually thereafter. Disease progression will be defined in these cases as the development of new thyroid cancers or metastases.
KoMPASS findings will help to confirm the role of AS, and develop individualized management strategies, for low-risk PTMCs.
一项针对甲状腺微小乳头状癌（PTMC）的韩国多中心前瞻性主动监测或手术队列研究（KoMPASS）已经启动。目的是比较低风险PTMC的主动监测（AS）和即刻肺叶切除术的临床结果。我们在此概述本研究的详细方案。
将纳入经细胞病理学确诊、超声（US）测量大小为6.0至10.0毫米的成年PTMC患者。如果患者有PTMC可疑的甲状腺外侵犯或转移、或多个甲状腺结节、或其他需要行全甲状腺切除术的甲状腺疾病，则将其排除。将向符合条件的患者提供描述PTMC预后以及每种治疗方案利弊的印刷材料，以便他们选择自己喜欢的干预措施。对于AS组，在第一年每6个月监测一次甲状腺超声、甲状腺功能和生活质量（QoL）参数，此后每年监测一次。疾病进展将定义为PTMC最大直径增加≥3毫米，或出现新的甲状腺癌或转移。如果检测到进展，患者应接受适当的手术。对于肺叶切除术组，将在6个月内进行预防性中央区颈淋巴结清扫的肺叶切除术。初次手术后，在第一年每6个月监测一次甲状腺超声、甲状腺功能、血清甲状腺球蛋白（Tg）、抗Tg抗体和QoL参数，此后每年监测一次。在这些病例中，疾病进展将定义为出现新的甲状腺癌或转移。
KoMPASS的研究结果将有助于确认AS对于低风险PTMC的作用，并制定个体化的管理策略。
