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韩国甲状腺微小乳头状癌主动监测或手术多中心前瞻性队列研究(KoMPASS)方案

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

作者信息

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

机构信息

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.

出版信息

Endocrinol Metab (Seoul). 2021 Apr;36(2):359-364. doi: 10.3803/EnM.2020.890. Epub 2021 Mar 23.


DOI:10.3803/EnM.2020.890
PMID:33752303
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8090471/
Abstract

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.

摘要

背景: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。 方法: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。 结论: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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324a/8090471/b552e3eb777f/enm-2020-890f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324a/8090471/b552e3eb777f/enm-2020-890f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/324a/8090471/b552e3eb777f/enm-2020-890f1.jpg

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[2]
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J Korean Soc Radiol. 2024-11

[3]
Standardized Ultrasound Evaluation for Active Surveillance of Low-Risk Thyroid Microcarcinoma in Adults: 2024 Korean Society of Thyroid Radiology Consensus Statement.

Korean J Radiol. 2024-11

[4]
Active Surveillance for Low-Risk Papillary Thyroid Carcinoma as an Acceptable Management Option with Additional Benefits: A Comprehensive Systematic Review.

Endocrinol Metab (Seoul). 2024-2

[5]
It Is Time to Understand the Additional Benefits of Active Surveillance for Low-Risk Papillary Thyroid Carcinoma.

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[6]
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[7]
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[8]
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[9]
Long-Term Outcomes of Active Surveillance and Immediate Surgery for Adult Patients with Low-Risk Papillary Thyroid Microcarcinoma: 30-Year Experience.

Thyroid. 2023-7

[10]
Lower Thyroid Cancer Mortality in Patients Detected by Screening: A Meta-Analysis.

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本文引用的文献

[1]
Marked Decrease Over Time in Conversion Surgery After Active Surveillance of Low-Risk Papillary Thyroid Microcarcinoma.

Thyroid. 2021-2

[2]
Quality of Life in Patients with Papillary Thyroid Microcarcinoma According to Treatment: Total Thyroidectomy with or without Radioactive Iodine Ablation.

Endocrinol Metab (Seoul). 2020-3

[3]
Active Surveillance of Papillary Thyroid Microcarcinoma: Where Do We Stand?

Eur Thyroid J. 2019-12

[4]
Surgery alone for papillary thyroid microcarcinoma is less costly and more effective than long term active surveillance.

Surgery. 2019-9-19

[5]
Computed Tomography for Detecting Cervical Lymph Node Metastasis in Patients Who Have Papillary Thyroid Microcarcinoma with Tumor Characteristics Appropriate for Active Surveillance.

Thyroid. 2019-9-26

[6]
Active Surveillance for Small Papillary Thyroid Cancer: A Systematic Review and Meta-Analysis.

Thyroid. 2019-9-27

[7]
Longitudinal Assessment of Quality of Life According to Treatment Options in Low-Risk Papillary Thyroid Microcarcinoma Patients: Active Surveillance or Immediate Surgery (Interim Analysis of MAeSTro).

Thyroid. 2019-7-12

[8]
Tumor Volume Doubling Time in Active Surveillance of Papillary Thyroid Carcinoma.

Thyroid. 2019-4-8

[9]
Active Surveillance of Low-Risk Papillary Thyroid Microcarcinoma: A Multi-Center Cohort Study in Korea.

Thyroid. 2018-10-17

[10]
Study Protocol of Multicenter Prospective Cohort Study of Active Surveillance on Papillary Thyroid Microcarcinoma (MAeSTro).

Endocrinol Metab (Seoul). 2018-6

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