Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Conditions
Thyroid Cancer
Conditions: official terms
Carcinoma, Papillary - Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Papillary thyroid carcinoma, Lymph node dissection, Lymph node metastasis, Prophylactic node dissection, Central lymph node metastasis
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Prophylactic central lymph node dissection
Type: Procedure
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age: 18 to 70

- Sonographically node-negative cytology confirmed thyroid papillary carcinoma

- Tumor size less than 1 cm in sonography

- Tumor confined to the one lobe of the thyroid gland

- One who provides the informed consent

Exclusion Criteria:

- History of radiation treatment to head and neck area

- History of other malignancy except thyroid cancer

- Poor performance status (ECOG 3-4)
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Han-Sin Jeong, MD, PhD - 82-2-3410-3577 - hansin.jeong@samsung.com
Start Date
January 2009
Completion Date
June 2014
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page