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

Fujian Medical University

Status: Unknown

Conditions: Thyroid Papillary Carcinoma

Treatments: Procedure: surgery：UCND（unilateral central lymph node dissection）; Procedure: surgery：BCND（bilateral central lymph node dissection）

Study type: Interventional

Funder types: Other

Identifiers

NCT02648399

wzhao

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

only unilateral center lymph node dissection

Treatment:

Procedure: surgery：UCND（unilateral central lymph node dissection）

experimental group

Experimental group

Description:

bilateral center lymph node dissection

Treatment:

Procedure: surgery：BCND（bilateral central lymph node dissection）