Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study

Conditions
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Carcinoma

Intervention / Treatment
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* Procedure: Routine central neck dissection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C group<br>Routine central neck dissection | Procedure: Routine central neck dissection<br>* Level VI neck node dissection during thyroid operation<br>|
| No Intervention: N group<br>No central neck node dissection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is routine neck node dissection necessary in micro PTC? | 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. | Until 5 year follow-up. (Dec. 2016) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of sentinel lymph node biopsy in micro PTC |  | Until 5 year follow-up. (Dec. 2016) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck dissection, sentinel lymph node, Carcinoma, Papillary, thyroid, dissection