Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)
3 year after initial treatment
Yes
Han-Sin Jeong, MD, PhD
Principal Investigator
Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
Korea: Food and Drug Administration
2008-09-048
NCT00795782
January 2009
June 2014
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