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

Endocrinology and Metabolism

Won Bae Kim¹  Min Ji Jeon¹  Bo Hyun Kim²  Ho-Cheol Kang³  Minho Shong⁴  Yea Eun Kang⁴  Min-Hee Kim⁵  Jae Hoon Moon⁶  Sun Wook Cho⁷  Dong Jun Lim⁸  Sun Wook Kim⁹  Chang Yoon Lee^1,10  Yong Sang Lee^1,11 

[1] Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea;Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Busan, Korea;Department of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun, Korea;Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea;Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea;Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea;Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea;Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea;Department of Medicine, Thyroid Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea;Department of Radiology, National Cancer Center, Goyang, Korea;Department of Surgery, Thyroid Cancer Center, Gangnam Severance Hospital, Institute of Refractory Thyroid Cancer, Yonsei University College of Medicine, Seoul, Korea;

关键词: active surveillance;    watchful waiting;    thyroid cancer;    papillary;    cohort studies;    comparative study;   

DOI  :  10.3803/EnM.2020.890

来源: DOAJ

【 摘 要 】

Background 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. 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 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. Conclusion KoMPASS findings will help to confirm the role of AS, and develop individualized management strategies, for low-risk PTMCs.

【 授权许可】

Unknown