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Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

This study is currently recruiting participants.
Verified July 2011 by Samsung Medical Center
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00795782
First received: November 19, 2008
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  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:

Drug Information available for: Thyroid
U.S. FDA Resources

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 ]

Estimated Enrollment: 258
Study Start Date: January 2009
Estimated Study Completion Date: June 2014
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795782

Contacts
Contact: Han-Sin Jeong, MD, PhD 82-2-3410-3577 hansin.jeong@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Han-Sin Jeong, MD, PhD     82-2-3410-3577     hansin.jeong@samsung.com    
Principal Investigator: Han-Sin Jeong, MD, PhD            
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: Han-Sin Jeong/Assistant Professor, Department of Otorhinolaryngology-Head and Neck Surgery, 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: July 21, 2011
Health Authority: Korea: Food and Drug Administration

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 Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
 Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013