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Brief Title: Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Official Title: Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial
Study ID: NCT00795782
Brief Summary: The purpose of this study is to determine whether the prophylactic ipsilateral central lymph node dissection is equally effective in the management of papillary thyroid microcarcinoma(PTMC) to the bilateral central lymph node dissection.
Detailed Description: The extent, the advantage and disadvantage of prophylactic central lymph node dissection was not fully established up to now in papillary thyroid microcarcinoma. Prophylactic bilateral central lymph node dissection can give a important clinical information about the status of lymph nodes, and possibly guide a further adjuvant treatment. However, it causes high postoperative morbidity, including hypocalcemia and hoarseness. In this respect, some advocate no central lymph node dissection in prophylactic settings. Thus, we aimed to prove the efficacy of prophylactic ipsilateral central lymph node dissection in thyroid papillary microcarcinoma, compared to the bilateral dissection and no dissection. Type of Study design: Prospective randomized, controlled double-blinded (to subjects and observers) study. Group I: Limited/ipsilateral central lymph node dissection (UniCND) Group II: Comprehensive/bilateral central lymph node dissection (BiCND) Group III: No central lymph node dissection (NoCND) Outcomes: vocal cord palsy, hypocalcemia, locoregional recurrence, distant metastasis
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Samsung Medical Center, Seoul, , Korea, Republic of
Name: Han-Sin Jeong, MD, PhD
Affiliation: Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
Role: PRINCIPAL_INVESTIGATOR