Prophylactic Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Phase 3

Completed

• Conditions: Thyroid Cancer
• Interventions: Procedure: Prophylactic central lymph node dissection

• Registration Number: NCT00795782
• Lead Sponsor: Samsung Medical Center

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.

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 Timeline

• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Study Start: 2009-01
• Status Verified: 2011-07
• Primary Completion: 2012-06
• Study Completion: 2014-06
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UniCND	Prophylactic central lymph node dissection	Limited/ipsilateral central lymph node dissection
BiCND	Prophylactic central lymph node dissection	Comprehensive/bilateral central lymph node dissection

Primary Outcome Measures

Name	Time	Method
Recurrence (Thyroglobulin level, antiTG level, results of follow-up imaging tools)	3 year after initial treatment

Secondary Outcome Measures

Name	Time	Method
Postoperative complications(hypocalcemia, hoarseness)	up to 3 years after surgery

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of