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

Thyroid Papillary Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02648399
• Other study ID #: wzhao
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2015
• Last updated: January 6, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Fujian Medical University
• Contact: wenxin zhao, doctor
• Phone: 08613365910359
• Email: fzhzwx6688[@]163.com
• Is FDA regulated: No
• Health authority: China:Fujian mediacal university union hospital
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Thyroid Neoplasms
• Thyroid Papillary Carcinoma

Intervention

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

• surgery:UCND(unilateral central lymph node dissection)

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor recurrence	numbers of patients with tumor recurrence	5 years	Yes
Primary	numbers of metastatic lymph node	numbers of metastatic lymph node	1 years	Yes
Primary	adverse events related to treatment	numbers of participants with adverse events including recurrent nerve injury,parathyroid injury,hemorrhage	1 years	No
Secondary	relations between the lymph metastasis and TNM staging	Coefficient R (SPSS software for correlation analysis)	1 years	Yes
Secondary	relations between the lymph metastasis and tumor location	Coefficient R (SPSS software for correlation analysis)	1 years	Yes