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A Multicenter, Randomized, Controlled Trial for Assessing the Usefulness of Suppressing Thyroid Stimulating Hormone Target Levels after Thyroid Lobectomy in Low to Intermediate Risk Thyroid Cancer Patients (MASTER): A Study Protocol

Authors
 Eun Kyung Lee  ;  Yea Eun Kang  ;  Young Joo Park  ;  Bon Seok Koo  ;  Ki-Wook Chung  ;  Eu Jeong Ku  ;  Ho-Ryun Won  ;  Won Sang Yoo  ;  Eonju Jeon  ;  Se Hyun Paek  ;  Yong Sang Lee  ;  Dong Mee Lim  ;  Yong Joon Suh  ;  Ha Kyoung Park  ;  Hyo-Jeong Kim  ;  Bo Hyun Kim  ;  Mijin Kim  ;  Sun Wook Kim  ;  Ka Hee Yi  ;  Sue K Park  ;  Eun-Jae Jung  ;  June Young Choi  ;  Ja Seong Bae  ;  Joon Hwa Hong  ;  Kee-Hyun Nam  ;  Young Ki Lee  ;  Hyeong Won Yu  ;  Sujeong Go  ;  Young Mi Kang 
Citation
 Endocrinology and Metabolism (대한내분비학회지), Vol.36(3) : 574-581, 2021-06 
Journal Title
Endocrinology and Metabolism(대한내분비학회지)
ISSN
 2093-596X 
Issue Date
2021-06
MeSH
Humans ; Multicenter Studies as Topic ; Prospective Studies ; Quality of Life* ; Randomized Controlled Trials as Topic ; Thyroid Neoplasms* / drug therapy ; Thyroid Neoplasms* / surgery ; Thyrotropin
Keywords
Recurrence ; Thyroid neoplasms ; Thyroidectomy ; Thyrotropin ; Thyroxine
Abstract
Background: Postoperative thyroid stimulating hormone (TSH) suppression therapy is recommended for patients with intermediate- and high-risk differentiated thyroid cancer to prevent the recurrence of thyroid cancer. With the recent increase in small thyroid cancer cases, the extent of resection during surgery has generally decreased. Therefore, questions have been raised about the efficacy and long-term side effects of TSH suppression therapy in patients who have undergone a lobectomy.

Methods: This is a multicenter, prospective, randomized, controlled clinical trial in which 2,986 patients with papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The dose of levothyroxine will be adjusted at each visit to maintain the target TSH level. The primary outcome is recurrence-free survival, as assessed by neck ultrasound every 6 to 12 months. Secondary endpoints include disease-free survival, overall survival, success rate in reaching the TSH target range, the proportion of patients with major cardiovascular diseases or bone metabolic disease, the quality of life, and medical costs. The follow-up period is 5 years.

Conclusion: The results of this trial will contribute to establishing the optimal indication for TSH suppression therapy in low-risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of recurrence, metabolic complications, costs, and quality of life.
DOI
10.3803/EnM.2020.943
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Nam, Kee Hyun(남기현) ORCID logo https://orcid.org/0000-0002-6852-1190
Lee, Yong Sang(이용상) ORCID logo https://orcid.org/0000-0002-8234-8718
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/190895
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