Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma

Study Overview
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Brief Summary
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This study recruit the patients with unilateral papillary thyroid cancer before operation,the patients agree to enter the test,and divided into experimental and control group.experimental group patients receive the surgery including unilateral thyroid lobectomy and bilateral central lymph node dissection.and control group receive the surgery including unilateral thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic lymph node,and numbers of participants with adverse events related to treatment between two groups in order to evaluate the significance of bilateral lymph node dissection.

Conditions
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Thyroid Papillary Carcinoma

Intervention / Treatment
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* Procedure: surgery：BCND（bilateral central lymph node dissection）
* Procedure: surgery：UCND（unilateral central lymph node dissection）


Participation Criteria
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Eligibility Criteria
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according by thyroid carcinoma TNM(tumor,lymph node, metastasis) staging of NCCN (National Comprehensive Cancer Network) Inclusion Criteria: 1.Unilateral thyroid papillary carcinoma 2.TNM staging: T1 2N0M0 Exclusion Criteria: 1.Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Placebo Comparator: control group<br>only unilateral center lymph node dissection | Procedure: surgery：UCND（unilateral central lymph node dissection）<br> <br> * Other names: only unilateral central lymph node dissection;|
| Experimental: experimental group<br>bilateral center lymph node dissection | Procedure: surgery：BCND（bilateral central lymph node dissection）<br> <br> * Other names: aad another central lymph node dissection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor recurrence | numbers of patients with tumor recurrence | 5 years | 
| numbers of metastatic lymph node | numbers of metastatic lymph node | 1 years | 
| adverse events related to treatment | numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relations between the lymph metastasis and TNM staging | Coefficient R (SPSS software for correlation analysis) | 1 years | 
| relations between the lymph metastasis and tumor location | Coefficient R (SPSS software for correlation analysis) | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid carcinoma, center lymph node dissection