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Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795782
First Posted: November 21, 2008
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samsung Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 19, 2008
First Posted: November 21, 2008
Last Update Posted: April 15, 2016
Last Verified: July 2011
Individual Participant Data (IPD) Sharing Statement:
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