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KMID : 1141520210360030574
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Endocrinology and Metabolism
2021 Volume.36 No. 3 p.574 ~ p.581
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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
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Lee Eun-Kyung
Kang Yea-Eun
Park Young-Joo
Koo Bon-Seok
Chung Ki-Wook
Ku Eu-Jeong
Won Ho-Ryun
Yoo Won-Sang
Jeon Eon-Ju
Paek Se-Hyun
Lee Yong-Sang
Lim Dong-Mee
Suh Yong-Joon
Park Ha-Kyoung
Kim Hyo-Jeong
Kim Bo-Hyun
Kim Mi-Jin
Kim Sun-Wook
Yi Ka-Hee
Park Sue-K.
Jung Eun-Jae
Choi June-Young
Bae Ja-Seong
Hong Joon-Hwa
Nam Kee-Hyun
Lee Young-Ki
Yu Hyeong-Won
Go Su-Jeong
Kang Young-Mi
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Abstract
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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.
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KEYWORD
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Thyroid neoplasms, Thyrotropin, Thyroxine, Recurrence, Thyroidectomy
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