Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00795782

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 III

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma: A Prospective Randomized Controlled Trial

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:	December 2013
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
UniCND: Experimental Limited/ipsilateral central lymph node dissection	Procedure: Prophylactic central lymph node dissection prophylactic ipsilateral versus bilateral central lymph node dissection
BiCND: Active Comparator Comprehensive/bilateral central lymph node dissection	Procedure: Prophylactic central lymph node dissection prophylactic ipsilateral versus bilateral central lymph node dissection
NoCND: No Intervention 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:	19 Years to 80 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
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:

Son YI, Jeong HS, Baek CH, Chung MK, Ryu J, Chung JH, So YK, Jang JY, Choi J. Extent of prophylactic lymph node dissection in the central neck area of the patients with papillary thyroid carcinoma: comparison of limited versus comprehensive lymph node dissection in a 2-year safety study. Ann Surg Oncol. 2008 Jul;15(7):2020-6. Epub 2008 May 6.

Responsible Party:	Samsung Medical Center ( Han-Sin Jeong/Assistant Professor, Department of Otorhinolaryngology-Head and Neck Surgery )
Study ID Numbers:	SMC IRB 2008-09-048
Study First Received:	November 19, 2008
Last Updated:	November 30, 2008
ClinicalTrials.gov Identifier:	NCT00795782
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

Study placed in the following topic categories:

Thyroid Neoplasms
Head and Neck Neoplasms
Neoplasm Metastasis
Endocrine System Diseases
Endocrinopathy

Thyroid Diseases
Thyroid cancer, papillary
Endocrine Gland Neoplasms
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009