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

January 6, 2016 updated by: wenxin zhao, Fujian Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
only unilateral center lymph node dissection
Procedure: surgery：UCND（unilateral central lymph node dissection）
Other Names:
  • only unilateral central lymph node dissection
Experimental: experimental group
bilateral center lymph node dissection
Procedure: surgery：BCND（bilateral central lymph node dissection）
Other Names:
  • aad another central lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor recurrence
Time Frame: 5 years
numbers of patients with tumor recurrence
5 years
numbers of metastatic lymph node
Time Frame: 1 years
numbers of metastatic lymph node
1 years
adverse events related to treatment
Time Frame: 1 years
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
Time Frame: 1 years
Coefficient R (SPSS software for correlation analysis)
1 years
relations between the lymph metastasis and tumor location
Time Frame: 1 years
Coefficient R (SPSS software for correlation analysis)
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Principal Investigator: wenxin zhao, doctor, Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wzhao

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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