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Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Thyroid Cancer

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)

Outcome Time Frame:

3 year after initial treatment

Safety Issue:

Yes

Principal Investigator

Han-Sin Jeong, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

Korea: Food and Drug Administration

Study ID:

2008-09-048

NCT ID:

NCT00795782

Start Date:

January 2009

Completion Date:

June 2014

Related Keywords:

  • Thyroid Cancer
  • Papillary thyroid carcinoma
  • Lymph node dissection
  • Lymph node metastasis
  • Prophylactic node dissection
  • Central lymph node metastasis
  • Thyroid Neoplasms
  • Thyroid Diseases

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