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

Not Applicable

• Conditions: Thyroid Papillary Carcinoma
• Interventions: Procedure: surgery：UCND（unilateral central lymph node dissection）; Procedure: surgery：BCND（bilateral central lymph node dissection）

• Registration Number: NCT02648399
• Lead Sponsor: Fujian Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-13
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-06
• Last Update Submitted: 2016-01-06
• Study First Posted: 2016-01-07
• Last Update Posted: 2016-01-07
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	surgery：UCND（unilateral central lymph node dissection）	only unilateral center lymph node dissection
experimental group	surgery：BCND（bilateral central lymph node dissection）	bilateral center lymph node dissection

Primary Outcome Measures

Name	Time	Method
numbers of metastatic lymph node	1 years	numbers of metastatic lymph node
tumor recurrence	5 years	numbers of patients with tumor recurrence
adverse events related to treatment	1 years	numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage

Secondary Outcome Measures

Name	Time	Method
relations between the lymph metastasis and tumor location	1 years	Coefficient R (SPSS software for correlation analysis)
relations between the lymph metastasis and TNM staging	1 years	Coefficient R (SPSS software for correlation analysis)

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China