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

Sponsor
Fujian Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02648399
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
12
Duration (Months)
24.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: surgery：BCND（bilateral central lymph node dissection）
  • Procedure: surgery：UCND（unilateral central lymph node dissection）
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. tumor recurrence [5 years]

      numbers of patients with tumor recurrence

    2. numbers of metastatic lymph node [1 years]

      numbers of metastatic lymph node

    3. adverse events related to treatment [1 years]

      numbers of participants with adverse events including recurrent nerve injury，parathyroid injury，hemorrhage

    Secondary Outcome Measures

    1. relations between the lymph metastasis and TNM staging [1 years]

      Coefficient R (SPSS software for correlation analysis)

    2. relations between the lymph metastasis and tumor location [1 years]

      Coefficient R (SPSS software for correlation analysis)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fujian Medical University Union Hospital Fuzhou Fujian China 350000

    Sponsors and Collaborators

    • Fujian Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    wenxin zhao, Director,Vise Head of Acscular and Thyroid Department,Principal Investigator, Clinical Professor, Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT02648399
    Other Study ID Numbers:
    • wzhao
    First Posted:
    Jan 7, 2016
    Last Update Posted:
    Jan 7, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by wenxin zhao, Director,Vise Head of Acscular and Thyroid Department,Principal Investigator, Clinical Professor, Fujian Medical University
    thyroid carcinoma
    center lymph node dissection
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Papillary
    Thyroid Cancer, Papillary
    Thyroid Diseases

    Study Results

    No Results Posted as of Jan 7, 2016