Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00795782
First received: November 19, 2008
Last updated: April 13, 2016
Last verified: July 2011
  Purpose
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.

Condition Intervention Phase
Thyroid Cancer
Procedure: Prophylactic central lymph node dissection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools) [ Time Frame: 3 year after initial treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Postoperative complications(hypocalcemia, hoarseness) [ Time Frame: up to 3 years after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 258
Study Start Date: January 2009
Study Completion Date: June 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UniCND
Limited/ipsilateral central lymph node dissection
Procedure: Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection
Active Comparator: BiCND
Comprehensive/bilateral central lymph node dissection
Procedure: Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection
No Intervention: NoCND
No 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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795782

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Han-Sin Jeong, MD, PhD Samsung Medical Center, Department of Otorhinolaryngology-Head and Neck Surgery
  More Information

Publications:
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00795782     History of Changes
Other Study ID Numbers: 2008-09-048 
Study First Received: November 19, 2008
Last Updated: April 13, 2016
Health Authority: Korea: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Samsung Medical Center:
Papillary thyroid carcinoma
Lymph node dissection
Lymph node metastasis
Prophylactic node dissection
Central lymph node metastasis

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Carcinoma, Papillary
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell

ClinicalTrials.gov processed this record on July 21, 2016