Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Phase 2

• Conditions: Carcinoma
• Interventions: Procedure: Routine central neck dissection

• Registration Number: NCT01149161
• Lead Sponsor: Samsung Medical Center

Brief Summary

Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.

Detailed Description

The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21
• Primary Completion: 2017-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• papillary carcinoma of thyroid (less than 4cm)
• no evidence of lymph node metastasis in preoperative work-up result
• the patients who accept this study

Exclusion Criteria

• large thyroid cancer( > 4cm)
• morbid
• anticoagulation agent usage
• endoscopic or robotic thyroid operation
• evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C group	Routine central neck dissection	Routine central neck dissection

Primary Outcome Measures

Name	Time	Method
Is routine neck node dissection necessary in micro PTC?	Until 5 year follow-up. (Dec. 2016)	To see the necessity of routine neck node dissection in micro PTC, we will compare the recurrence rate and other complication (e.g. hoarseness and hypocalcemia) between group I(no dissection) and group III(routine dissection) after completion of study(after 5 year f/u).; To check the safety of this study, our result will be checked by korea institutional reveiw board every one year.

Secondary Outcome Measures

Name	Time	Method
The efficacy of sentinel lymph node biopsy in micro PTC	Until 5 year follow-up. (Dec. 2016)

Trial Locations

Locations (1)

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