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

Primary Purpose

Thyroid Papillary Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
surgery：BCND（bilateral central lymph node dissection）
surgery：UCND（unilateral central lymph node dissection）
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Papillary Carcinoma focused on measuring thyroid carcinoma, center lymph node dissection

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

experimental group

Arm Description

only unilateral center lymph node dissection

bilateral center lymph node dissection

Outcomes

Primary Outcome Measures

tumor recurrence
numbers of patients with tumor recurrence
numbers of metastatic lymph node
numbers of metastatic lymph node
adverse events related to treatment
numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage

Secondary Outcome Measures

relations between the lymph metastasis and TNM staging
Coefficient R (SPSS software for correlation analysis)
relations between the lymph metastasis and tumor location
Coefficient R (SPSS software for correlation analysis)

Full Information

First Posted
December 13, 2015
Last Updated
January 6, 2016
Sponsor
Fujian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02648399
Brief Title
Prospective Study on the Clinical Prognosis of Bilateral Central Lymph Node Dissection in the Patients With Unilateral Thyroid Papillary Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Papillary Carcinoma
Keywords
thyroid carcinoma, center lymph node dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
only unilateral center lymph node dissection
Arm Title
experimental group
Arm Type
Experimental
Arm Description
bilateral center lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
surgery：BCND（bilateral central lymph node dissection）
Other Intervention Name(s)
aad another central lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
surgery：UCND（unilateral central lymph node dissection）
Other Intervention Name(s)
only unilateral central lymph node dissection
Primary Outcome Measure Information:
Title
tumor recurrence
Description
numbers of patients with tumor recurrence
Time Frame
5 years
Title
numbers of metastatic lymph node
Description
numbers of metastatic lymph node
Time Frame
1 years
Title
adverse events related to treatment
Description
numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage
Time Frame
1 years
Secondary Outcome Measure Information:
Title
relations between the lymph metastasis and TNM staging
Description
Coefficient R (SPSS software for correlation analysis)
Time Frame
1 years
Title
relations between the lymph metastasis and tumor location
Description
Coefficient R (SPSS software for correlation analysis)
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wenxin zhao, doctor
Phone
08613365910359
Email
fzhzwx6688@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
shouyi yan, master
Phone
0861598230279
Email
yansy1985@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wenxin zhao, doctor
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wenxin zhao, doctor
Phone
08613365910359
Email
fzhzwx6688@163.com
First Name & Middle Initial & Last Name & Degree
shouyi yan, master
Phone
08615980230279
Email
yansy1985@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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