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Spots Global Cancer Trial Database for Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

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Trial Identification

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

Conditions

Thyroid Cancer

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Samsung Medical Center, Seoul, , Korea, Republic of

Contact Details

Name: Han-Sin Jeong, MD, PhD

Affiliation: Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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