Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795782
• Other study ID #: 2008-09-048
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2008
• Last updated: April 13, 2016
• Start date: January 2009
• Est. completion date: June 2014

Study information

• Verified date: July 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: June 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Prophylactic central lymph node dissection
prophylactic ipsilateral versus bilateral central lymph node dissection

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. doi: 10.1245/s10434-008-9928-8. Epub 2008 May 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)		3 year after initial treatment	Yes
Secondary	Postoperative complications(hypocalcemia, hoarseness)		up to 3 years after surgery	Yes