Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00795782
• Collaborator: (none)
• Enrollment: 258
• Location: 1
• Arms: 3
• Duration (Months): 65
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer	Procedure: Prophylactic central lymph node dissection	Phase 3

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• 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
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools) [3 year after initial treatment]

Secondary Outcome Measures

1. Postoperative complications(hypocalcemia, hoarseness) [up to 3 years after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

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

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT00795782
• Other Study ID Numbers: 2008-09-048
• First Posted: Nov 21, 2008
• Last Update Posted: Apr 15, 2016
• Last Verified: Jul 1, 2011

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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 Neoplasms; Thyroid Diseases

Study Results

No Results Posted as of Apr 15, 2016